IVD Audits: medical devices put to the test

An IVD audit is the most effective way to gain assurance that you, as a manufacturer or distributor of IVDs, are able to meet all requirements.

Metecon supports you comprehensively in this area with a lot of experience and know-how. Get an overview of our services.

And if you see a need:
We'd, love to hear from you!
Probably the best known:

ISO 13485:2016

your proof that you provide IVD/medical devices and related services that meet customer requirements and applicable regulations.

When was your last internal audit?

For many IVD manufacturers, the requirements for the quality management system have changed with the IVD Regulation. As one of the first steps in implementing the IVDR, you should therefore check which requirements are now placed on your QMS. Among other things, it should be noted that the new version of EN ISO 13485:2016 has already been mandatory since mid-2019.

Internal audits with Metecon auditors have proven successful for our customers because we prepare you optimally for QM audits: We uncover possible weak points, determine the effectiveness of your QMS and help to implement appropriate measures accordingly. In this way, you prevent deviations by your notified body.

The results of an audit are an important building block for your management review. We would be happy to discuss with you the benefits, the process and the effort required for an internal audit.

Learn now how internal audits work with us

Our services as follows

  • 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)
    • Therapeutic Goods Administration (TGA), Australia.

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