The Future of Validation and Verification in Medical Device Manufacturing

Regulatory criteria are tightening as the field of medical devices continues to develop. Technological developments have produced smaller, more intricate devices that frequently make use of cutting-edge plastics. Processes for validation and verification (V&V) have become extremely important in this situation. They not only make sure that laws are followed, but they also help to create high-quality components and manufacturing procedures. In this essay, we explore current V&V trends to clarify their importance and potential in the future.

Landscape of Medical Devices’ Verification and Validation

Validation and Verification concepts

The creation of medical devices must include both validation and verification. Validation makes ensuring that the intended purposes and user needs are met objectively. To make that a medical device consistently provides the expected medical benefit of real-world use circumstances, it entails tests, inspections, and analyzes. Verification focuses on factual proof that the design input requirements are met. It includes tests, inspections, and analyzes, just like validation.

V&V industry expectations

Today’s medical device firms look for regulatory-compliant V&V activities that are efficient, pertinent, and well-documented. International standards and the regulatory environment influence V&V activity. Engineering in human aspects is getting a lot of attention. Specialized methods like formative and summative testing are in line with the recommendations made by ANSI/AAMI HE75:2009 and ISO’s IEC 62366:2007. These standards provide information on the methods used in testing, design, and usability engineering. The FDA also offers guideline documents that are useful resources for learning about human factors engineering.

Modernizations in V&V

The standardization of V&V activities has facilitated the streamlining of manufacturing and approval processes. Automation and sophisticated diagnostic tools have improved V&V procedures even more. Companies that make medical devices adhere to a rigorous development process with clear deliverables at each stage. Every specification must provide verification and/or validation evidence and risk management strategies.

The Best Time for V&V

Early consideration of V&V is essential because it is essential to incorporate V&V factors while creating required specifications for a product. Modularity, accessible connectors, data storage/retrieval capabilities, and test points on circuit boards are a few examples of design features that can make testing easier and ultimately, more time and money efficient. Costs associated with V&V can be decreased by using previously tested materials or coatings. Besides influencing the ultimate design and overall manufacturable, clear, succinct, measurable, accurate, and testable specifications also provide acceptance criteria for later V&V operations.

Future of V&V in the Development of Medical Devices

Because of the regulatory framework, the field of V&V in medical devices does not undergo significant change. However, methods for enhancing results and efficiencies will keep developing. We may expect better V&V techniques, automated testing tools, and documentation tools being available as the regulatory environment develops.


Validation and verification are essential in maintaining the safety and efficacy of medical devices in a regulatory environment that is always changing. Companies that manufacture medical devices are aware of how crucial compliant and well-documented V&V activities are. Companies can expedite their manufacturing by taking V&V into account early in the design stage and using the most recent innovations.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.