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PRIMED INSTRUMENTS INC.

PriMed Instruments has successfully achieved ISO13485:2016 and MDSAP certification for our QMS as well as market authorization for CROC® Single use Biopsy Forceps.

ISO13485:2016 is the international quality management standard for designers and manufacturers of medical devices. PRIMED has actively pursued this certification as part of an ongoing commitment to quality service.

The scope of the registration applies to:

Design, manufacture, and distribution of endoscopic instruments, including non-sterile reusable biopsy forceps, sterile disposable biopsy forceps and retrieval devices, non-sterile reusable and disposable cleaning brushes and non-sterile tissue collection devices. Provision of manufacturing service for catheter subassembly.


VIEW THE ISO 13485:2016 MDSAP PAGES
DOWNLOAD THE ISO 13485:2016 MDSAP PDF