What To Know
Reaching the design verification phase of your medical device development is a major milestone. What happens at this stage? Your development team confirms that all design inputs match the design outputs. The design verification phase is part of ISO 14971 and responds to QMS standards such as ISO 13485. Design verification confirms that the device design meets the specifications. It is the primary safety check of requirements within the ISO 13485 Design Control Standards checklist.
When the design verification aligns sufficiently to meet the standard, your device is approaching the 501(k) application submission and final product approval.
The process is delayed if any inputs fail to satisfy one or more output requirements. Your team must go back to find the source of the problem and identify corrective measures.
How We Can HelpI3 Infotek offers a wide range of support for the countless issues that can arise during design verification. We can correct flawed inputs, for example, or manage product testing, such as:
- Packaging integrity testing (to ensure sterility)
- Design and process failure modes and effects analyses
- Design and process fault tree analysis
- Materials testing (for biocompatibility)