All medical device innovators face the challenge of meeting the ever-increasing demands of the FDA and other regulatory bodies to bring life-altering medical devices to market. For US submissions for market clearance, meeting the requirements of Design Control (21 CFR Part 820.30) is every bit as important as testing for biocompatibility, efficacy, functional performance and safety.
iuvo BioScience offers the unique opportunity to not only perform the testing required to support a medical device application (510(k), PMA, CE Marking / Designation), but also to ensure strict adherence to the expectations of Design Control. Our team has decades of experience in bringing medical devices to market from the Research and Development stage and effectively works with our clients’ service providers (such as contract manufacturers) to ensure the appropriate documentation is in place to support the application, as well as during the lifecycle of the device. We have the necessary procedures, work instructions and forms to ensure our clients’ success in meeting the Design Control requirements. The areas covered include the following:
- Project Planning
- Stage-Gate Review Process
- Design Inputs / Outputs
- Design Verification & Validation (V&V)
- Risk Management
- Design Change Management
Contact us today to discuss how iuvo can support all of your Design Control needs.