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Three years ago, Anne Wilson only had three staff members at QA Consulting Inc., a firm based in Austin, TX. Fast forward to today, and Wilson has tripled her staff. “There are now eight full-time and at least six contracted employees,” she says.

The experience of QA Consulting isn’t unusual. Some medical device quality consulting firms are reporting more business from device manufacturers due to what they describe as heightened oversight by the U.S. Food and Drug Administration (FDA).

Device makers hire quality system consultants for a variety of tasks. These consultants can help manufacturers get regulatory approval for a device, comply with a standard, set up a quality system—which helps to ensure product safety and efficacy—and prepare for an FDA inspection after a product reaches the public.

Edwin Bills, principal consultant of Bilanx Consulting LLC, says that he has hardly spent any time in his Sumter, SC, office this year with all of his travel for clients. He says business has increased about 30% from last year.

“I have had conversations with other consultants that have experienced an increase in requests for assistance,” says Bills. Wilson says the FDA has hired more inspectors, and conducted more inspections of manufacturers.

Wilson gave an example of a new company inspected six months after its first device received regulatory approval. “In the past, a company would sometimes go years and not hear from the FDA,” she says.

Not only are companies seemingly facing more scrutiny from the FDA, “but also regulations, standards, and guidance documents are changing,” Bills says. “As a consultant, I have to constantly study changes, and determine how the new information will impact my clients.”


Complying With 60601-1

Michael Schmidt says his consulting business has picked up.

As the principal consultant with Strategic Device Compliance Services in Cincinnati, OH, Schmidt helps European and American companies comply with standards and regulations.

He says some international and domestic manufacturers need help implementing 60601-1, an international standard that was updated in 2005. It provides the general requirements for designing safe and effective electronic devices.

Many countries’ notified bodies, organizations accredited by the European Union to approve devices, set a deadline of June 2012 to implement it.

“The end of the transition date for 60601-1 has everyone hopping,” Schmidt says. “That is creating a fair amount of activity.” The 2005 edition calls for companies to implement risk management, and a new amendment was published with additional information on how to meet that requirement.

Originally published by AAMI News.