Oxebridge Quality Resources International has stopped offering ISO 13485 QMS implementation for medical device manufacturers, after having done so for over ten years. The following statement was issued by Oxebridge VP Operations, Christopher Paris:
Effective immediately, Oxebridge will no longer offer ISO 13485 implementation or training. This is prompted by our careful analysis of the new ISO 13485:2016 standard, as well as the perfect storm of dramatic changes being driven by new FDA regulations, and European Commission directives for CE Marking. Simply put, the simultaneous changes put dramatic pressures on medical device manufacturers, all at once, and Oxebridge feels it no longer has the appropriate in-house expertise to support all these requirements.
We hope that Oxebridge clients will understand the decision, and respect it. We have found too many consultants offering services for standards they do not fully understand, and we do not want to be in that group. We feel to do so is dangerous, and puts clients at risk of having poorly-implemented, inefficient management systems at best, or worse, at risk of finding themselves in violation of law.
We will continue to help clients find an appropriate and satisfactory resource for their ISO 13485 needs, but referring them to consultants who specialize in medical devices and nothing but medical devices.
Oxebridge, meanwhile, will continue to strengthen its focus on aerospace, through AS9100 implementations, as well as ISO 9001, CMMI and other standards that remain within its core competencies.
The Oxebridge website is undergoing changes to update previous pages that offered these services. The company will maintain its ISO 13485 forum within the O-Forum, however, to continue to host discussions on the topic.
