Use performance, safety, business economics, outputs of risk management and regulatory requirements as a basis to design the device so that its purpose and the intended use are clear. From concept through development to approval, the Medical Device Life Cycle integrates design, development, validation, and commercialization. All while becoming more cost-effective to install and maintain. We help you with the implementation from the standardized what into the normal how. That’s why employing best practices for mass manufacturing and consistently providing products and spare parts on time and up to specification, is of paramount importance. Like other industries, Medtech innovation starts with analyzing and identifying the market, the need of which is untapped or unmet or there is a more efficient way to address those particular needs. U.S. Food and Drug Administration. Understanding and consideration of the complicated clinical and regulatory requirements early in the product lifecycle could ensure your company gains a competitive advantage by reducing time to market. The design history file (DHF) compiles evidence (that is, the history of the design) that shows that the design was developed in accordance with design controls―specifically, the design and development plan, or the design-change plan. Manage product requirements with our systematic and repeatable solution for building-in the voice of the customer, enabling medical device companies to easily capture, securely manage, accurately verify, and reliably maintain requirements information across the entire device lifecycle. Meet essential requirements necessary to achieve a high-quality product, from inception through to production. It takes veteran manufacturers who are specialized in the field of interventional cardiology equipment, to be able to smoothly navigate through this ever-evolving market. All Rights Reserved. ● Creating a shared language for all aspects of the process, which enables effective communication and troubleshooting Benefits of utilizing NPD principles From the early stages of device components design, factors such as practical manufacturing limitations, ease of components assembly, and cost-efficient processing, should be taken into account. Application Lifecycle Management. United States Code. Medical Device Design. Quasar © Copyright 1988 - 2016. Erfahren Sie, wie Oracle PLM einen digitalen Thread mit Produkt- und IoT-Daten bereitstellt, um Ihre Entwicklungs- und Einführungsprozesse für neue Produkte widerstandsfähiger zu machen und schnellere und qualitativ hochwertige Innovationen voranzutreiben. Undertaking high yield mass manufacturing of the medical device product developed, poses a lot of challenges in order to provide products on time, within budget, and most importantly with excellent quality of manufacture. In the context of medical device product development lifecycle, the term technology transfer refers to effectively transferring all of the knowledge gained from the conception, design and development phases, to the mass production phase. Prevent potential issues or recalls in the future. Design controls for medical devices are regulated by the FDA under 21 CFR 820.30. (2011). Manage changes in related requirements with automated suspected links notifications. The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. FDA Design Controls. All aspects are geared towards a specific process methodology capable of achieving low production times, production line and workstations optimization, and overall production cost-effectiveness. Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This field is for validation purposes and should be left unchanged. ● Streamlining the supply chain for achieving both consistent delivery times, as well as competitive purchase cost for every BOM item of the medical device. The design control process includes a set of interrelated practices and procedures that are documented and incorporated during the medical device design and development. For medical device manufacturers, device uptime is more than just a statistic. Development of a new therapeutic product normally begins with non-clinical testing followed by different phases of human clinical trials in support of the licensing application. This article describes the design process during the product development of a new medical device. By Nico Krüger. The idea for new medical devices, like most new product innovations, often stems from the discovery of an unmet market need — in this case, products that can help people better monitor and manage their health, aid providers in improving care delivery, or devices that enable better treatment administration. Design output procedures or specifications need to stipulate or refer to the design input document developed by the team and need to identify the critical measures/outputs for the proper function of the device. These needs could be anything that delivers a solution such as a new or better way of monitoring health, enhanced care delivery solutions, devices or technologies to deliver better administration or anything that supports health and a human life.These … Process Flow Diagram (PFD) Developing IEC 62304 compliant software for medical devices is not a trivial thing. Medical device product development is a highly integrated and regulated process. Because design verification is conducted while the design work is being performed, design validation confirms that the medical device meets its intended use. This is where having an experienced partner to collaborate with can make all the difference. This is very similar to the design control elements of ISO 13485. Information taken into account can include outside sources such as feedback from the customer or their clients and inside sources such as feedback from the manufacturing plants’ Quality Assurance department. Through a PFMEA analysis, it is possible to identify and prioritize risk factors throughout the medical device product development lifecycle. Confirm the device design via examination and objective evidence, verify that the design outputs meet the design inputs. This is achieved through continuous process improvement in a cycle in which the medical device manufacturing team receives feedback and proceeds with optimizing and improving upon the production processes, in order to resolve any issues and produce an improved product. OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans. Strategically automating a process provides the best way to ensure the medical device’s manufacturing success. Design for Manufacturing (DFM) focuses on adapting, from an engineering perspective, the product, its components, and/or any elements associated with its assembly, to mass production capabilities and parameters. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Establish and maintain a plan that describes the design and development activities and allocates the individual responsibilities for each activity. Within this scope, the New Product Introduction (NPI) methodology is used, which aims to optimize the production process without compromising quality, by means of: FDA Review FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it. Ensure the design is reviewed by personnel from all areas involved with this stage as well as by someone who does not have direct responsibility for this design stage. Every healthcare product is unique and therefore so is its associated product development lifecycle. * In essence, design controls are simple and logical steps to ensure that what you develop is what you meant to develop, and that the final product meets your customer’s needs and expectations.2,3. Design controls are simple and logical steps to ensure that what you develop is what you. By submitting the form you agree to receive relevant information, products, and services that may be of interest to you. A table comparing the two approaches is presented in the article Healthcare product development―Step 6: Execute your healthcare product development plan. The benefits of transferring production to an experienced contract manufacturer with a track record for performance is the plethora of ideas and innovation that adds more value to the design of the end product. These include the tests and procedures that may have been developed, adapted or used to show conformance with the defined design inputs. Regulatory agencies require that you implement a design control process. Nortech Medical Solutions is the Medical Device focused product development and manufacturing offering of Nortech Systems. The Four Phases You Should Prepare for When Considering Manufacturing a Medical Device Product Development Lifecycle 1. If you add GDPR and 21 CFR 820 to this equation, you can get easily lost. Quasar is committed to protecting and respecting your privacy and you may unsubscribe from these communications at any time. A properly designed & developed medical device product has been optimized and prepared for mass manufacturing. Validate the device design via examination and objective evidence, confirm that the final design output consistently meets the specific intended use. ● Production line verification and validation (PVV), testing and documenting the capability for manufacturing the medical device product as specified. Chapter 2. Here we’ll explain what the two activities are, the difference between them, plus share tips for getting the most out of your efforts. The ITL Product Development Lifecycle is an overview of the complete service that we provide from conceptualisation right through to aftersales servicing and support. A deep understanding of regulatory, its impact on product development, and what it takes to comply requires years of working on these types of projects and a dedication to truly understand what is needed to bring a medical device to market. Ensure that all design changes are identified, documented, validated, verified, reviewed and approved prior to implementation. It also drastically speeds up transitioning from the design to the mass manufacturing phase. New Process Development (NPD) Most design verification activities become DHF records that support the effectiveness of design outputs (for example, risk analysis and management results, test method validations, software verification, biocompatibility results, transit test, and third-party certifications). Study results (for example, validation and biocompatibility studies, storage and shipping tests), DeMarco, C.T. Implementation of solution-based requirements tracking requires attention to a variety of nuanced topics. Software life cycle according to IEC 62304. In the buyer’s guide, "Improving Service Performance and Patient Outcomes with Remote Device Monitoring". Be reasonably sure that the end product works and meets customer needs. Medical device product design should be carried out with manufacturing in mind. For information on the product development lifecycle for a new drug or biologic, please see Product development lifecycle: New drug development. All Rights Reserved, Product development lifecycle: New drug development, Healthcare product development―Step 6: Execute your healthcare product development plan, Quality system: Medical device product development, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30. By supporting new products from ideation to manufacturing, we leverage a best in class approach – at each stage of the … This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. Pre-Process Failure Mode Effect Analysis (Pre-PFMEA) Further your understanding of the phases, requirements, and deliverables of the Device Life Cycle in order to manage projects and multifunctional teams. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020. PLM-Software (Product Lifecycle Management), mit der Unternehmen schnell neue Produkte entwerfen und auf den Markt bringen können? © 2021 Copyright MaRS Discovery District. Document the design review results (for example, the design identification, date and individual[s] performing the review) in the design history file (DHF). From one-off and per-item costs to quality, repeatability, and customer satisfaction. In the product development of a medical device, the design stage is critical to ensure you build an effective and safe device. These needs aren’t always obvious to the target user, as common problems are often regarded as inconveniences that must b… You may unsubscribe at any time. Medical Device Requirements Management. Consequently, start-ups should tailor this ‘master list’ of milestones to their own unique set of circumstances. Assessing the Intellectual Property During the Product Development Lifecycle. Two common types of review are hazard analysis, and failure mode and effect analysis. Design & Development TGA pre-market review; Production; Supply TGA post-market monitoring; Use, maintenance and disposal; Slide 2 - Premarket supply pathway. After conceptualizing a new medical device, the next step in its product development is the design. Usually this is established through in vitro performance, functional testing, animal testing and/or in vivo clinical evaluations and trials. Where are you in the medical device product development lifecycle? Product Development Lifecycle Consulting for Medical Devices We focus all aspects of the development process with the single goal of turning your medical advance into a successful brand. Requirements Management. Cybersecurity and the Medical Device Product Development Lifecycle. 1 Specify, manage, and document your requirements throughout the device’s development lifecycle in collaboration with all stakeholders. If you develop products — medical devices, particularly — then you’ve heard the terms design validation and design verification (also called V&V). You have to develop software in line with its intended use and compliant with ISO 13485, ISO 14971, and IEC 62304 standards.. ● Assisting in identifying potential points of failure and preemptively resolving them from the development process, ensuring a smooth transition to the production with a minimum of setbacks Medical device and diagnostic solutions: A life cycle development model that moves your device ahead of the game 28 October 2019 (Last Updated April 24th, 2020 08:47) The medical device and diagnostic (MDD) industry is experiencing a transformational era due to huge advances in technologies such as AI, robotics, mobile apps, combination products and patient-enabled diagnostic tests. Expand the fields below to read how Minerva Medical Device PLM can address some of the biggest business challenges in the industry. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device … MANAGING THE LIFECYCLE OF MEDICAL EQUIPMENT. (2003). For life sciences innovators, improving lives is what counts—but for many, distributed teams and disconnected data impede innovation and put product quality at risk. An experienced contract manufacturer utilizes New Process Development (NPD) principles, that include several techniques necessary to achieve seamless transitioning from design to manufacturing phase. With the right people, process, and tools in place, you can focus on what matters most: developing breakthrough products … Justiniano, J., Gopalaswamy, V. & Kirkland, H.B. Design verification activities must be planned and routinely examined and the results must be documented. Title 21, Part 820.30. An important distinction and critical element of any design control that defines a product life cycle (PLC) is that it can play a critical role during a medical device audit or for demonstrating design-control compliance. China’s overall economic recovery in part has been attributed to the strong rebound in the manufacturing sector. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device that is effective to use, feasible to produce, and can achieve regulatory compliance. Our team helps medical device companies accelerate the commercialization process through a fully integrated Product Lifecycle offering. Review and address information gathered as you develop the product specifications. Designed in line with our ISO 13485 and FDA GMP quality management system, our Product Development Life-cycle encompasses all of the services that we offer. Ensure you review, update and approve the plan until the device design is completed, verified and validated. This enables an effective, fast and smooth production process. Now, it is possible to implement a coordinated effort that integrates the four core components of the medical product lifecycle—preclinical, clinical, regulatory, and post-market. (1997). Work with Pro4People, a IEC 62304 software development partner that knows this domain inside out. The identified risk factors are then addressed from the design phase, removing major barriers for proceeding to production. Contact us to discover how Quasar’s 30-year experience, infrastructure, and know-how, can help you bring your medical device to market. In the competitive medical device market place, ensuring that product development meets all regulatory requirements is essential. Ensure that the design of the medical device can be correctly translated into production specifications (that is, advancing successfully from product development to manufacturing). Life cycle of medical devices - Lifecycle approach to regulation & the importance of reporting incidents to the TGA Slide 1 - Lifecycle approach to regulation . CONTENTS About this guide 2 The Equipment Life Cycle 3 Phase 1: Planning 4 Phase 2: Budgeting & Financing 6 Phase 3: Technology Assessment & Selection 8 Phase 4: Procurement & Logistics 10 Phase 5: Installation & Commissioning 11 Phase 6: Training & Skill development 12 Phase 7: Operation & Safety 14 Phase 8: Maintenance & Repair 15 … *This article discusses the design control process based on the requirements outlined in Title 21, Section 820.30 of US Code of Federal Regulations. Through design control activities, a company can: The US 21 CFR 820.30 design control requirements are outlined below:1-5. To find out more, please visit our Privacy Policy. The medical devices manufacturing sector specifically recorded an astounding 46.4% growth. Once a medical device product launches, it will be used to help patients in hospitals and even operating ER rooms, where every small detail plays a critical role. Understanding and consideration of the complicated clinical and regulatory requirements early in the product lifecycle could ensure your company gains a competitive by reducing time to market. Choosing the right partner to develop and produce your medical device products, plays a critical role in how you bring your products to market and can make or break a medical device product’s success. Processes for the life cycle of medical device software. Hospitals, clinicians, and patients around the world rely on your devices to ensure optimal care. A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy, Automation Trends in Medical Device Manufacturing, 6 Advantages of Medical Device Manufacturing in China Post Covid-19, Benefits of Transferring Production to An Experienced Contract Manufacturer, Interventional Cardiology Equipment: Top Advancements of 2020, How Automation Benefits Your Bottom Line in Medical Device Production. Step 1 Conformity Assessment TGA; European Notified Body; 2 Step … The development, pre-clinical, and clinical processes can and will vary from one medical device start-up to the next, depending on the type of product, the company’s go-tomarket strategy and its ability to raise capital. Design validation should follow successful design verification. Ensure each product meets all requirements. Many supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance. This is the most important stage in the development of a medical device since a flawed design may lead to it being ineffective or unsafe (that is, not approved or cleared by the regulatory agency).1 At the design stage, a design control process needs to be initiated and implemented as part of the quality system requirement. 2.0 The Medical Device Product Development Lifecycle There are a number of different product development lifecycles used to design and develop medical devices … Additionally, refer to Table 1 in the article Quality system: Medical device product development for information on whether it is mandatory for you to meet design control requirements as part of your quality system requirements. Medical device makers who automate product engineering best practices consistently achieve better outcomes. Design for Manufacturing (DFM) Chemistry, Manufacturing and Controls (CMC) activities are conducted concurrently to support these studies. The PFMEA is an analytical tool used to identify and evaluate the potential failures of a process. Conception. Developing a PLC in tandem with a solid product development process (PDP) provides the necessary cornerstones for complete design-control and device-management compliance. Today’s advancements in automation systems are evolving at a fast pace. Specific advice should be sought from a qualified healthcare or other appropriate professional. NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. Following the initial design phase, a PFD is developed to layout and describe in detail all of the medical -device’s assembly steps. The design control process follows a set of practices and procedures that help medical product developers: Manage quality. Product development lifecycle: Medical device design and development Input may also come from surveying your customers (for example, clinicians, nurses, patients). In. It all starts with the requirements. Where are you in the medical device product development lifecycle? Identify early inconsistencies or discrepancies by comparing what is currently made to the initial concept (thereby reducing redesign and rework and improving product design and quality―that is, getting it right the first time). Establish and maintain a plan that describes the design and development activities and allocates the individual responsibilities for each activity. In the competitive medical device market place, ensuring that product development meets all regulatory requirements is essential. Examples of design outputs may include: Confirm the design, or detect early on and correct any deficiencies identified at other design and development phases. Ensure you review, update and approve the plan until the device design is completed, verified and validated. ICS Medical Devices’ Unique Approach to the Product Development Lifecycle January 19, 2021 / Latest Thinking, Resources At ICS Medical Devices we love a challenge – when a client brings us something that pushes the boundaries and tests the limits of what is currently possible. This helps identify critical processes and preemptively avoid issues down the line, saving you money. This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. Prior to implementation ’ s advancements in automation systems are evolving at a fast pace companies must and... So is its associated product development meets all regulatory requirements is essential design phase, removing major barriers proceeding... Validation medical device product development lifecycle and failure mode and effect analysis product development―Step 6: Execute your healthcare product development―Step 6 Execute. Of milestones to their own unique set of interrelated practices and procedures that be! An experienced partner to collaborate with can make all the difference your Privacy you... Medical device PLM can address some of the biggest business challenges in the article healthcare product development―Step 6: your! Adapted or used to show conformance with the implementation from the standardized what into the how. And approve the plan until the device design is completed, verified and validated may. Where are you in the buyer ’ s guide, `` Improving Service Performance and Patient outcomes Remote. Auf den Markt bringen können medical device product development lifecycle device design and development Phases, requirements, and around. Follows independent healthcare investment firm ArchiMed ’ s development lifecycle for a new medical device approaches presented... Design to the strong rebound in the article healthcare product development―Step 6 Execute... J., Gopalaswamy, V. & Kirkland, H.B manage changes in related requirements with automated suspected notifications... At a fast pace design controls for medical device Life Cycle of device. Meets its intended use normal how PLM can address some of the biggest business challenges in article... The end product works and meets customer needs uptime is more than just a statistic includes a set of and... Customers ( for example, clinicians, and document your requirements throughout the devices! Where are you in the competitive medical device ’ s overall economic recovery in part has attributed... Been developed, adapted or used to show conformance with the implementation from the standardized into! A highly integrated and regulated process is where having an experienced partner to collaborate with can make all difference! 13485, ISO 14971, and services that may be of interest to you include the tests and procedures help... In mind you should Prepare for When Considering manufacturing a medical device makers who automate product engineering practices. Manage changes in related requirements with automated suspected links notifications changes in related requirements with automated suspected links.! Failure mode and effect analysis in related requirements with automated suspected links notifications inside out shipping! Can make all the difference ’ s manufacturing success you in the competitive device. All the difference effective and safe device to achieve a high-quality product from! Und auf den Markt bringen können and solve supply-chain vulnerabilities stem from lead! Of a new medical device product development of a medical device companies accelerate the commercialization process a... Or other appropriate professional are outlined below:1-5 and incorporated during the medical devices is not trivial... Factors throughout the device ’ s overall economic recovery in part has been optimized and prepared for manufacturing... Product, from inception through to production partner to collaborate with can make all the difference validate the design..., start-ups medical device product development lifecycle tailor this ‘ master list ’ of milestones to their own unique set of.! Via examination and objective evidence, confirm that the medical device product has been and. Plc in tandem with a solid product development of a medical device companies the... To their own unique set of practices and procedures that are documented and incorporated during the medical device place... And logical steps to ensure you review, update and approve the plan until the device design is completed verified. S development lifecycle and validated device uptime is more than just a statistic guide, `` Improving Service Performance Patient... This is where having an experienced partner to collaborate with can make the! By creating effective mitigation and business-continuity plans biggest business challenges in the medical device the! Describes the design to the design process during the product development of new. Issues down the line, saving you money company can: the US 21 CFR 820 to this,... Maintain a plan that describes the design to the strong rebound in the competitive medical device market,. Product has been attributed to the design control process 820.30 design control activities, a IEC compliant! Line with its intended use provides the best way to ensure you build an effective, medical device product development lifecycle and smooth process. Read how Minerva medical device PLM can address some of the Phases, requirements and. S advancements in automation systems are evolving at a fast pace output consistently meets the intended. Design changes are identified, documented, validated, verified and validated product works and meets needs! Order to manage projects and multifunctional teams relevant information, products, and customer satisfaction verified, reviewed approved! Issues down the line, saving you money you review, update approve! Helps medical device, the medical devices are regulated by the FDA under 21 CFR 820.30 simple logical. Build an effective, fast and smooth production process ensure you build an effective and safe device of cyclicity prevent! Just a statistic the product development lifecycle in collaboration with all stakeholders and business-continuity.... To collaborate with can make all the difference partner that knows this domain inside out are. Production process to production, you can get easily lost interest purchase of NAMSA in 2020... Your devices to ensure you review, update and approve the plan until device! Patients around the world rely on your devices to ensure you build an effective and safe device these... Iso 13485 the form you agree to receive relevant information, products, and services that may be of to. Approve the plan until the device design via examination and objective evidence, that. Stage is critical to ensure optimal care costs to medical device product development lifecycle, repeatability, and IEC 62304..... Necessary cornerstones for complete design-control and device-management compliance development partner that knows domain... Quality, repeatability, and IEC 62304 compliant software for medical devices not... High-Quality product, from inception through to production phase, removing major for... The healthcare product development meets all regulatory requirements is essential tracking requires attention to a variety of nuanced.. Prepared for mass manufacturing are evolving at a fast pace implement a design control process of ISO,! And effect analysis attributed to the design phase, removing major barriers for proceeding to production and that., requirements, and document your requirements throughout the medical devices manufacturing sector recorded. Control process the industry and multifunctional teams verified, reviewed and approved prior to implementation standardized what into normal. Results ( for example, clinicians, nurses, patients ) are hazard analysis, is... Animal testing and/or in vivo clinical evaluations and trials and services that may of! And trials in mind come medical device product development lifecycle surveying your customers ( for example clinicians! Performance and Patient outcomes with Remote device Monitoring '' with can make the. Automate product engineering best practices consistently achieve better outcomes projects and multifunctional teams approved prior to implementation intended and... Optimized and prepared for mass manufacturing phase this field is for validation purposes and should be left unchanged as! Manage changes in related requirements with automated suspected links notifications fast and smooth production process links notifications be unchanged. Risk exposures by creating effective mitigation and business-continuity plans stage is critical ensure! Is established through in vitro Performance, functional testing, animal testing and/or in vivo clinical evaluations and trials Intellectual! Concept through development to approval, the medical devices is not a trivial thing includes a set of practices procedures..., removing major barriers for proceeding to production see product development lifecycle 1 end product works and meets needs. Drastically speeds up transitioning from the standardized what into the medical device product development lifecycle how control requirements are outlined below:1-5 topics. Development lifecycle 1 validated, verified and validated device, the next in! Utilizing NPD principles a properly designed & developed medical device design is completed verified., Gopalaswamy, V. & Kirkland, H.B two common types of review are hazard,... Comparing the two approaches is presented in the product development lifecycle is very similar the!, V. & Kirkland, H.B to you identify and solve supply-chain vulnerabilities stem from long lead and... In related requirements with automated suspected links notifications in these articles is intended to outline the general processes principles! The article healthcare product development lifecycle concepts of the device ’ s economic. To show conformance with the defined design inputs information, products, deliverables... Speeds up transitioning from the design and development examined and the results must be documented, animal testing and/or vivo! Healthcare or other appropriate professional interrelated practices and procedures that help medical product:... Evaluations and trials you should Prepare for When Considering manufacturing a medical device Life Cycle of medical device product lifecycle... Design validation confirms that the end product works and meets customer needs design and development activities and allocates the responsibilities. To collaborate with can make all the difference 820.30 design control elements of ISO 13485, 14971. Manage, and services that medical device product development lifecycle have been developed, adapted or used to show conformance with implementation! Development Assessing the Intellectual Property during the product development meets all regulatory is! Your requirements throughout the device design is completed, verified, reviewed and prior! Patients around the world rely on your devices to ensure you review update... Your Privacy and you may unsubscribe from these communications at any time gathered as you develop what! Show conformance with the defined design inputs because design verification is conducted while the and. More than just a statistic this enables an effective, fast and production! Namsa in September 2020 specifically recorded an astounding 46.4 % growth product lifecycle Management ), mit der Unternehmen neue.