We are often asked to provide medical device product verification help as part of the outsourced product development projects with which we work. Even for large organizations that have brought many products to market, properly navigating the verification process and ensuring documentation is complete and thorough can be an overwhelming task.
The verification step in product development is critical to the success of a product, particularly in heavily regulated industries. Possibly one of the most important steps in the overall product development lifecycle, verification assesses the developed product to ensure that all the design input requirements have been met. In the simplest terms, the verification process leverages independent testing to provide objective evidence that the implementation of the design meets the product or subsystems design requirements and the intended use of the product.
Verification answers the question, does this product or subsystem do what it was designed to do?
While it may sound simple, performing the verification step is complex and requires a detailed understanding of both the design input requirements across areas such as mechanical software, hardware and shipping, and a clear knowledge of the documentation requirements needed.
As mentioned above, for companies developing products in the Medical Device or Life Sciences industries, verification obligations to the FDA or other regulatory body are a significant part of the overall submittal process and may typically require multiple, detailed verification deliverables.
Next week we will be releasing a whitepaper, “Understanding the Requirements of Product Verification”, the provides a high-level overview of some of the components of the verification process, including:
- Requirements building
- Documentation strategy
- Testing plans
- A sample verification process
- Creating protocols
- Guidelines on what it means to pass verification
Many companies need medical device product verification help as part of their project. If your business is at any stage in the product development lifecycle, and verification is a concern, talk to Resolution to ensure your project is on track to cross this significant milestone.