What is the best approach to private labeling medical devices? скачать в хорошем качестве

What is the best approach to private labeling medical devices?

There is an overseas device manufacturer, and I want to private label their device. Can you help me? Yes, of course. Medical Device Academy is a full-service quality and regulatory consulting firm. We help dozens of clients with private labeling. Before we start, we first need some basic information: 1. What's the device? 2. Does the manufacturer have 510(k) clearance? 3. Will you be importing? or just distributing? 4. Are you changing the packaging or labeling? 5. Do you have a quality system? 6. Who is the US Agent? https://fda-us-agent.com/ - our website for US Agent services You also need to determine which roles your company will be responsible for: 1. initial importer 2. complaint file establishment 3. repackager/relabeler If you need help with registration and listing, here's an FDA link: https://www.fda.gov/medical-devices/d... Critical things to consider: 1. Who will have the UDI & GUDID account? 2. Who will handle complaints? 3. What will happen if there is a recall? 4. Does the supplier have liability insurance?