PriMed Instruments has successfully achieved ISO13485:2016 certification as well as CE certification 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 reusable biopsy forceps, disposable biopsy forceps, reusable cleaning brushes, disposable cleaning brushes and tissue collection devices. Provision of manufacturing service for catheter subassembly.