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.