The trend recently has involved at least one phone call or email per week from a medical device company requesting help–either full-time or consulting–in the areas of quality and regulatory. And the requests are coming from all types of medical device companies.
As a consulting firm providing solutions in quality and regulatory, I’m a little excited about this trend. But this also has me a little concerned, mainly because I want to understand why the sudden surge.
Are companies suddenly struggling with FDA regulations and ISO requirements? Are companies expanding into new markets requiring expertise from seasoned experts? Are companies losing resources? I honestly don’t know the answers. But I can tell you it has been difficult to find people to fill the requests.
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