ISO 13485 – Medical Device Manufacturing Standard

Effective November 2016, Oxebridge is no longer offering ISO 13485 implementation services. We have assessed the changes made as a result of the ISO 13485:2016 standard, alongside simultaneous changes in regulatory requirements by FDA and European Directives, and do not feel confident we have the in-house expertise to provide the relevant supporting services.

If you require assistance in implementing ISO 13485, email Oxebridge and we may be able to put you in contact with a suitable consulting firm.