Frequently Asked Questions

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1. What qualifies a product as a "medical device"?

2. How are medical devices classified?

3. What is the difference between "medical device qualification" and "certification"?

4. How do regulatory requirements differ between the FDA and the European MDR?

5. What is post-market surveillance, and why is it essential?

6. How does software qualify as a medical device?

7. What are the consequences of non-compliance with medical device regulations?

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