News & Articles

The Truth About FDA Regulated OEM Servicing


Since the beginning of the FDA 3rd Party Service docket, more than 5 years ago, there has been an abundance of misinformation introduced by some stake holders regarding a number of issues. Just a few examples: who exactly a 3rd Party servicer is, does a 3rd Party servicer include hospital employed HTMs, do hospitals and 3rd party servicers have a “right” to repair their own MRI? The latest misinformation recently published in LinkedIn was a reader response to a published article entitled “How Right to Repair Thwarts Free Enterprise,” in which the reader of this article made the astonishingly ignorant statement that “OEMs are self-regulated in their service programs as well. I am not aware of any of the OEM’s whose service divisions are actually ISO certified, rather they fall under ISO “Compliant” whereas many independent service organizations are actually certified in either ISO 9001 or 13485 with true audits unlike the OEM’s who have internal audit for their service organizations.”

To put that lie to the torch, it took me all of five minutes to find and download one certificate from Philips Medical Systems. In addition to being ISO13485:2016 certified, Medical Device Manufacturers (OEMs) also fall under the FDA Quality System Regulation “Good Manufacturing Practices (GMP) – 21 CFR Part 820, which includes service (see Figure 1). As it states in Figure 1, Manufacturing (OEM) facilities undergo FDA inspections to assure compliance with QS requirements.” So, the claim made above that OEMs are “self-regulated” when it comes to servicing their products is both ignorant and perhaps intentionally misleading.

Having been responsible for both FDA inspections and ISO audits I can assure the reader that an FDA site inspection is an order of magnitude more comprehensive than an ISO audit. There is simply too much misinformation and ad hominid hyperbole going on against medical device OEMs to take these R2R advocates (agitators) seriously. They are hurting their own cause by spreading false information. 

Until next month,

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September 21, 2021 Newsletter