Friday, August 10, 2012

"Big Box" Regulatory Affairs Consulting Groups

Credible Medical Products Regulatory Affairs and Quality Systems consulting groups are facing the influx of what I call “Big Box” medical consulting groups.  These groups advertise as experienced medical products consultants with group rate discounts and very low billing rates.  Initially these rates are attractive to customers who often times do not know to ask the questions to verify credentials.  By the time the customers realize they are receiving sub par and inaccurate advice as well as poor quality work it is often times to late.  These customers have already spent the money with low cost consultants and then find themselves with FDA problems.

Recently I reviewed one of these low cost consulting firms advertising for medical device consulting candidates.  The ad read “should have basic understanding of FDA regulations.”  When a company is hiring a consultant it is hiring that firm for its expertise.  This is not a “learn as you go assignment.”  The medical products consultant needs to be extremely knowledgeable on every facet of the FDA regulations not to only “have a basic knowledge.”  It is a regulatory consultant’s job to provide highly credible advice and superior work to make the customer’s job easier. 

My advice is Beware of these Big Box low cost consulting firms.”  I have seen where these consulting groups are only interested in a quick turnaround by supplying their customers with unqualified bodies at the expense of their customers.

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.