Home CertificationISO 14971 Risk Management for Medical Devices
ISO 14971 Risk Management for Medical Devices Certification
The ISO 14971 Risk Management for Medical Devices Certification is meticulously designed to guide participants through the essential aspects of risk management specific to medical devices. The Certification begins with an introduction to the ISO 14971 standard, focusing on its scope, the critical terms, and definitions that underpin the rest of the curriculum.
In subsequent modules, the Certification explores the detailed processes involved in risk analysis, evaluation, control, and the evaluation of overall residual risk acceptability. Participants learn how to identify potential hazards, estimate risks, and implement effective risk control measures.
What You Will Learn?
This certification enables professionals in the medical device sector to develop, implement, and maintain a risk management system that complies with international standards. It equips them with the skills to identify and mitigate risks effectively, enhancing device safety and efficacy and supporting regulatory compliance.
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