FDA Quality Management System —>QMSR “On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality

Reach out to discuss if your product is impacted. Do you meet the definition of Responsible Person? RESPONSIBLE PERSON. — as defined in section 604(4)

Yes, if the device continues to design and intended for the specific use that is within the regulation you say applies. If your promotional material

But I added the disclaimer statement, I am in compliance, right? You know this one… This statement has not been evaluated by the Food and

When preparing for a medical device submission to the FDA, sponsors always ask, “What do I need to do?”  The answer is, it depends.  Expectations

Welcome to my site. The regulators have been busy. There are changes with FDA submission expectation, European Medical Device Regulations are going into effect soon, Health