CAM's European manufacturing facility is based in Leiden, The Netherlands, and is certified by TÜV Product Services (Munich) to EN-ISO 9001:1994 and EN 46001:1996 standards. In addition to meeting ISO requirements, our Quality System also meets the "US Quality System Regulation for Medical Devices," ensuring that quality and service are maintained at the highest level. Our customers are welcome to audit our facility for quality and regulatory compliance.

CE mark and FDA files
Based on its Quality System and its vast knowledge of coating technology and related biosciences, CAM Implants has developed two distinct tools with which we actively support customers who apply for regulatory approval.

The Type Examination Certificate from TÜV Product Services conforms to EC Directive 93/94, annex 3 & 5, for hydroxyapatite (HA) powders and coatings of orthopedic implants. The certificate is covered by our HA coating file and by the relevant marketing claims, and can be referenced by our customers when applying to Authoritative Bodies for CE Mark approval.

The US FDA Master file with specifications, test protocols and results of CAMCERAM® HA coatings and powders, is available for reference to all of our customers for their master filing (IDE, 510K, PMA) and use when contacting the US authorities.