FDA Medical Device Postmarketing Regulatory Affairs |
BRC provides comprehensive device regulatory affairs support, as well as selected services, for device manufacturers interested in outsourcing postmarketing regulatory services.
Once a medical device is on the market, manufacturers as well as other firms involved in the distribution of devices must comply with relevant requirements and regulations.
Once a medical device is on the market, manufacturers as well as other firms involved in the distribution of devices must comply with relevant requirements and regulations.
Postmarketing Services for Medical Devices
For companies outsourcing postmarketing device services, BRC provides the following services:
- Management of postmarketing device tracking systems.
- Reporting of device malfunctions, serious injuries or deaths.
- Registration of establishments where devices are produced or distributed.
- Device Listing.
- Postmarketing surveillance strategies.
- Monitoring post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE) or product development protocol (PDP) application.
- Amended or new indications for cleared/approved medical devices, and associated device labeling.
- Renovation of QSR compliance for manufacturing changes of cleared/approved medical devices.
- Among other services.
