Medical Device Quality Services

TÜV Rheinland can help you get to market faster. We provide the medical device market a faster approval process for the ultra-competitive European Union market. Medical device certification from TÜV Rheinland grants consumers the reassurance that a medical device or product meets all appropriate safety standards. As an accredited third-party by OSHA as a NRTL, CMDCAS, as well as the Standards Council of Canada (SCC), TÜV Rheinland can provide certification for compliance with numerous international regulations. Our medical auditing programs examine your company's management and production operations to determine compliance with the relevant standards and regulations. In addition, as a single source for all testing and certification needs, we can perform conformity assessments to all European Medical Device Directives for CE Marking.

Active Implantable Medical Devices (AIMD)

TÜV Rheinland provides services for implantable devices in accordance with AIMD Directive 90/385/EEC

In-Vitro Diagnostic Device Directive (IVD)

TÜV Rheinland offers the mandatory compliance testing requirements for IVD Directive 98/79/EC

Medical Device Directive (MDD)

TÜV Rheinland provides a wide range of regulatory assessment services to help manufacturers get to market faster.

Japanese PAL

TÜV Rheinland provides solutions for the mandatory Japanese Pharmaceutical Affairs Law (PAL)

ISO 13485 Certification

TÜV Rheinland offers quality management systems certification in accordance with ISO 13485