Wednesday, December 23, 2009

Hiring a Medical Device Regulatory Affairs Consultant

The importance of hiring the right Regulatory Affairs consulting professional is critical to the success of your company. As the economy continues to waver and company downsizing continues, it appears that more unqualified people decide to become medical products regulatory affairs consultants. These "RA consultants" come from their previous job ranks of engineering, marketing, and operations. Because they had some previous minimal exposure to the regulatory process they believe that they can provide the necessary expertise required to navigate the FDA product approval regulation requirements.

Important questions to qualify your regulaltory affairs consultant should be:

1. How many devices have you taken successfully through the regulatory process?
2. How many years have you been a "Regulatory Affairs" professional?
3. Who do you know at the FDA?

These questions are easily verified and should be considered minimal requirements before choosing your regulatory affairs consultant.


  1. The Clinical Research Services (CRS) group of WorkSure Clinical Research Organization is a full-service Clinical Research Company

  2. Hey,I am glad this topic is being discussed. FDA warnings came out in 2011 stating mesh complications are NOT rare, are very severe, often permanent. However, I was not aware of those warnings, or the way medical devices are FDA approved prior to when I had a TOT mesh implant in Feb 2012. I have been suffering since that time - barely able to walk. I had to go across the country to a specialist to have it removed 3 months ago. I am still recovering and not sure if I will have perm. damage o not.Thanks you so much!!!