Regulatory dossier
Certifications & regulatory paperwork
Orthoprovet sells regulated medical devices. We hold and publish the supporting paperwork so procurement teams can validate the chain of custody without emailing back and forth. Tender-pack originals are available on request — use the quote form and ask for the regulatory dossier.
Certificates available on request
Our tender-pack includes CE Declarations of Conformity, ISO 13485 quality certificates, and FDA 510(k) clearances where applicable. Tell us the device family and we'll send the full pack within one business day.
Need something specific for your tender?
Test reports, per-lot certificates, biocompatibility data and country-specific declarations are available on request. Tell us the device family and the destination country and a sales engineer sends the full pack within one business day.