"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.
