Hi Sheila, Another webpage that may be helpful for you is at the link below, particularly the IDE Exempt Investigations section.  If you are using the device in accordance with its already cleared or approved indications for use and labeling, an IDE is not required. Without knowing all the details, it sounds like this may be the case for you.  I'd ...

​Yes, a great book I read years ago: Seeing the Big Picture: Business Acumen to Build Your Credibility, Career, and Company by Kevin Cope https://www.amazon.com/Seeing-Big-Picture-Business-Credibility/dp/1608322467 Also, I find being good at personal finances helps (lots of books on that, including Laura Adams, Jane Bryans Quinn, Dave Barry, etc). ...

Hi Ary (et. al.), I really appreciate the discussion. I know that notified bodies (auditing organizations) are really worried about the number of organizations that need to complete the transition, but do not fear and you will get there. The only issue I have is this propensity to call talk about risk management of QMS processes. That is NOT the requirement. ...