What is Verification and Validation?

Validation is the process of ensuring you have objective evidence that user needs, and the device’s intended uses are met. This is usually done with tests, inspections, and analysis. The goal of validation is to make sure the medical device meets the user needs consistently, provides the intended medical benefit, and remains the case when actually used in the real world.

Verification is ensuring you have objective evidence that the medical device’s specified requirements are met. This is usually done with tests, inspections, and analysis as well.

What do you need to be compliant?

Manufacturers need effective, relevant and well documented validation and verification activities that are compliant with EU regulations. Its very important to consider validation and verification early in the design phase when developing the device requirement specifications. This will streamline the overall manufacturing and approval processes.

The standards for validation and verification are set by regional regulatory bodies as well as international standards which often overlap when it comes to device requirements.

Planning for verification and validation is essential. We can provide project management for the definition of the tests to be performed and plans for that testing need to take place early in the development process. We understand that the V&V process connects the outcomes to the original specifications, but those outcomes also form the basis for a successful submission.

How can Clin-r+ help?

CLIN-r+ has a broad range of project management services and works with the top testing houses to ensure our clients deadlines are met on time, on budget and aligns with your conformity strategy for CE marking.

CLIN-r+ converts your GSPR checklist to a Validation Master Plan and matches suitable Common and Harmonised Standards to demonstrate conformity. We also identify the verification testing needs and create a Validation Master Plan to outline the overall strategy. Our clients find this invaluable to ensure that their processes and systems comply with quality, safety, and regulatory standards.

We also create biocompatibility plans and, if needed, project manage your biocompatibility evaluation requirements. Then structuring biocompatibility reports where report findings can be understood.

Need more details?

We are here to assist. Contact us, set up a meeting, join our mailing list or follow us on LinkedIn.

You can also check out these white papers on our MedTech Academy:

• Clinical Investigations for Medical Devices and IVD
• Biocompatibility
• Biocompatibility Evaluation
• Risk Management
• Clinical Evaluation for Medical Devices