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The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors.

Where others train followers, we train leaders™

ISO 14971 Training Courses

ISO 14971:2012 is the specified standard for risk management used to demonstrate compliance with the Risk Management requirements of the Medical Devices Directive (MDD) and the In Vitro Diagnostic Device Directive (IVDD). Additionally, review of the MDD by the European Commission concluded that manufacturers did not address risk management sufficiently, hence the increased emphasis on risk requirements in the update to the MDD. The revision to ISO 14971 has also been implemented to address these requirements.

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