The FDA’s office for the Medical Device Single Audit Program (MDSAP) has confirmed it has opened an investigation into the partnership announced by certification body Intertek and medical device consultant Globizz. At the same time, the accreditation bodies SWEDAC (Sweden) and SCC (Canada) have begun a review of the partnership.

Intertek is accredited under ISO 17021-1 which prohibits performing consulting services to its certification clients, or partnering with a third-party consultancy for such services. Nevertheless, Intertek published a widespread set of press releases announcing its partnership with Japanese consulting firm Globizz, and linked the certification and consulting services in those press releases.

The arrangement is troubling because it would focus mainly on medical devices and related healthcare products, thus calling into question the quality of those products if certifications were issued without impartiality and objectivity.

The issue was originally raised informally with Intertek and key representatives, including its Technical Director, Jorge Correa. Correa nor any of the other Intertek representatives responded, prompting Oxebridge to file a formal complaint.

at the same time, Oxebridge notified the FDA, which confirmed it would investigate the matter.

SCC recommended that any MDSAP complaint in Canada be filed with that nation’s MDSAP administrative body, Health Canada. SCC did confirm, however, that Intertek’s ISO 13485 certification services fall under its accreditation with SCC.

SWEDAC confirmed it was closely monitoring the situation, but was waiting on Intertek’s response.

Oxebridge was notified of the Intertek/Globizz partnership through its international ISO Whistleblower Program reporting tool.

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Since 2000, Oxebridge has worked to improve ISO and related certification schemes by identifying problems and then proposing solutions. We report on issues affecting standards users because so few other news outlets do. Our belief is that in order to fix the problems in these schemes, we must first understand the nature and breadth of those problems. Our reporting aims to do just that. Elsewhere on the Oxebridge site you will find White Papers and other articles proposing ideas to correct these problems.

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