Webinar: How to set up post-market surveillance for your medical device
ฝัง
- เผยแพร่เมื่อ 27 ก.ย. 2024
- 💥Medical device manufacturers are required to establish an effective post-market surveillance process as part of their quality system to ensure continued safety and effectiveness of their products.
👉This proves to be very difficult in practice. One reason is that a lot of resources are taken up by the Complaints Handling process required for regulatory compliance.
❌But complaints handling is NOT surveillance.
✅ In this webinar, we review the requirements for post-market surveillance according to ISO 14971, the standard for risk management.
✅We are also sharing a simple organizational structure and best practices to establish a working model to efficiently handle a large portfolio of medical devices.
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