Ongoing Postmarket Compliance
If quality assurance problems do arise once your medical device has entered the market, either in the U.S. or internationally, Aptiv Solutions will work with you to respond quickly and re-establish compliance.
To help maintain postmarket compliance for your medical device, we will:
- Perform EU Vigilance Reporting
- Develop appropriate enforcement action responses and/or corrective action plans in response to FDA 483s and warning letters
- Develop effective product recall strategies, including notification to applicable regulatory agencies and customers
- Assist with postmarket surveillance to address complaint handling, failure investigation, problem reporting, and device tracking