Confidence Beyond Compliance
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Frequently Asked Questions
- Is the product we are developing a medical device?
- How do we determine the classification for our device?
- Can we utilize the 510(k) regulatory pathway for US market authorization?
- How do we register our facility and list our products with the FDA?
- What is required to be on product labeling?
- Do you provide services for U.S. Agent/Offiical Correspondent?
- How do we prepare for an FDA inspection?
- What procedures are needed to implement a compliant quality system?
- What is the best approach for complying with new EU MDR requirements?
- What is the best way to respond to an FDA 483 and how do we address remediation?