Audits: medical devices put to the test

An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements.

Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our services. And if you see any need, we look forward to discussing a solution with you!

Probably the most familiar one:
ISO 13485:2016 - your proof that you provide medical devices and pertaining services that fulfill the customers’ needs and comply with the requirements of applicable regulations.
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Our services in this field

  • Conducting audits and supplier assessments,
  • Supporting our customers in external certification audits,
  • Auditor activities regarding quality management systems in accordance with:
    • MDD 93/42/EEC Medical Devices Directive
    • IVDD 98/79/EC In Vitro Diagnostic Directive
    • ISO 13485 Medical Devices - Quality Management Systems
    • AIMDD 90/385/EEC Active Implantable Medical Devices Directive
    • 21 CFR 820 Quality System Regulation
    • 21 CFR 210/211 cGMP
    • 21 CFR Part 4: Current Good Manufacturing Requirements for Combination Products
    • Canadian Medical Devices Regulation (CMDR): CAN/CSA ISO 13485 (CMDCAS)
    • Japanese Pharmaceutical Affairs Law (PAL) and J-GMP
    • Taiwan Technical Cooperation Program (TCP)
    • Brazil Medical Devices Regulation (ANVISA/INMETRO)
    • Korea Good Manufacturing Practice (K-GMP).