How to survive an FDA inspection! Part 2 Surviving an FDA Inspection Part 2 In Part 1 we discussed the key logistics involved with the FDA visiting your facility and the types of inspections they might wish to perform. Initial inspections, routine inspections and Quality System Surveillance Inspections are the most common. The FDA publishes […]
How to survive an FDA inspection! Part 1 It’s a Friday, late morning or early afternoon. You’re in the conference room with a few other executives of your medical device company. Also in the room is an inspector from the US Food and Drug Administration, the FDA. The inspector showed up the previous Monday for […]
Is it a Business, Engineering, or Regulatory Decision? Is it an Engineering, Regulatory or Business Decision? After being in the medical device industry for over 30 years and consulting for hundreds of clients over the last 10 years it’s amazing how often medical device developers get confused about what kind of decisions they must make; […]
Great is the Enemy of Good – Be Smart With Your Startup! Things are looking good! You’ve raised some money for your new medical device startup and are ready to take your idea to the next level – from a back-of-the-envelope notion into real product development. You know the process. You have a Quality System […]
