Verification & Validation: Quick Tips
14/01/2022
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In this blog, we explain why you should give special attention to Verification & Validation (V&V). We bring a special focus to this blog post: how you can use V&V to achieve your business goals.
Verification and Validation (V&V) are among the most important tools in quality management and quality assurance. Quality, in this context, refers to the degree to which requirements—both internal and external—are met in accordance with specifications, expectations, and agreements. The importance of verification & validation for manufacturers of medical devices is quickly revealed by examining the mentions of the terms in the most important regulations: The frequency with which a term is mentioned provides an indication of how important it is and therefore also an indication of the content on which the regulations place particular emphasis.
Table 1: Term Frequency
Given the “New Approach,” it is not surprising that the focus of the Medical Device Regulation (EU 2017/745) is on risk management. Similarly, Quality is the core emphasis of the standard for quality management systems (DIN EN ISO 13485:2016). Both documents also place a clear emphasis on the validation of medical devices, with ISO 13485:2016 particularly focuses on the importance of verification.In total, Verification and Validation (V&V) are mentioned 167 times. This makes it clear that V&V in medical technology is strongly interlinked in the context of regulatory and normative requirements; without a thorough examination of each citation, it is certainly not possible to create documentation that is suitable for certification or approval in the EU. A first step towards such documentation is the consistent processing of all citations in order to compare them with optimal solutions or solution strategies. Anyone who has to deal intensively with verification and validation from a regulatory point of view alone will obviously need to use these tools in the company for other conformity, compliance and optimization objectives.
As a manager or executive, you constantly ask yourself:
These focal points were additionally formulated for stakeholders in the medical technology sector:
So, how do you ensure that you can address each of these focal points?The solution lies within you and your team. However, your success largely depends on the application of methods for risk management and quality assurance. We know from frequent feedback of our newer clients that the topic of verification and validation can raise many questions, especially when encountered for the first time.We hope that our quick tips on verification and validation offers you initial assistance in this area.Best regards, and see you soon!
The importance of verification and validation is measurable
Verification and Validation (V&V) are among the most important tools in quality management and quality assurance. Quality, in this context, refers to the degree to which requirements—both internal and external—are met in accordance with specifications, expectations, and agreements. The importance of verification & validation for manufacturers of medical devices is quickly revealed by examining the mentions of the terms in the most important regulations: The frequency with which a term is mentioned provides an indication of how important it is and therefore also an indication of the content on which the regulations place particular emphasis.
Table 1: Term Frequency
Given the “New Approach,” it is not surprising that the focus of the Medical Device Regulation (EU 2017/745) is on risk management. Similarly, Quality is the core emphasis of the standard for quality management systems (DIN EN ISO 13485:2016). Both documents also place a clear emphasis on the validation of medical devices, with ISO 13485:2016 particularly focuses on the importance of verification.In total, Verification and Validation (V&V) are mentioned 167 times. This makes it clear that V&V in medical technology is strongly interlinked in the context of regulatory and normative requirements; without a thorough examination of each citation, it is certainly not possible to create documentation that is suitable for certification or approval in the EU. A first step towards such documentation is the consistent processing of all citations in order to compare them with optimal solutions or solution strategies. Anyone who has to deal intensively with verification and validation from a regulatory point of view alone will obviously need to use these tools in the company for other conformity, compliance and optimization objectives.
Business Goals in Medical Technology: V&V as a model for success?
As a manager or executive, you constantly ask yourself:
- What are the major risks I need to manage?
- How do I ensure that information in my company is available where it is helpful or needed?
- How do I direct and optimize my process results?
- How do I ensure the satisfaction of all stakeholders?
These focal points were additionally formulated for stakeholders in the medical technology sector:
- Compliant integration and use of artificial intelligence,
- Cost-effective assurance of cybersecurity.
So, how do you ensure that you can address each of these focal points?The solution lies within you and your team. However, your success largely depends on the application of methods for risk management and quality assurance. We know from frequent feedback of our newer clients that the topic of verification and validation can raise many questions, especially when encountered for the first time.We hope that our quick tips on verification and validation offers you initial assistance in this area.Best regards, and see you soon!
Our blog posts are researched and created with the utmost care, but are only snapshots of the regulations, which are constantly changing. We do not guarantee that older content is still current or meaningful. If you are not sure whether the article you have read on this page still corresponds to the current state of regulation, please contact us: we will quickly place your topic in the current context.
