ISO 14971 -standard

ISO 14971 is a key risk management standard for medical device manufacturers.

What is ISO 14971?

The ISO 14971 standard specifies the requirements for risk management throughout the medical device lifecycle. The aim is to ensure product safety and performance for the intended purpose determined by the manufacturer. Various regulations (e.g. MDR, IVDR) require the inclusion of risk management in organisations’ activities. Similarly, ISO 13485 requires defined and implemented risk management processes in several activities thorughout the organization. Indeed, risk management should be incorporated into an organisation’s day-to-day operation and aim to ensure controlled solutions and activities in all circumstances.

Kasve’s experts have vast experience in implementing risk management plans, conducting risk assessments, planning risk mitigation measures, following the effectiveness of measures and preparing risk management reports in accordance with ISO 14971. We will provide you with diverse support related to risk management activities.

 

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