When you’re developing products being introduced in the medical device industry, the design and functionality are important, but reliability and confidence in the design are an absolute must. In a heavily-regulated environment, simple failures can lead to significant consequences, including the complete shutdown of your product line, or worse, your organization. Moreover, you need to be able to clearly illustrate how you’ve addressed these concerns and mitigated risks to both internal QA/RA groups and the FDA.
Verification and Validation are likely the most critical steps in the development process and Syncroness is well-versed in how to perform V&V completely, protecting you from future product issues. By developing, reviewing and releasing a formal Verification Plan, we are able to ensure all stakeholders are in tune with how verification will be performed, including the applicable individual verification procedures which either already exist from prior efforts and [...]