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ISO 14971 Risk Management.

Risk management is an integral part of all phases of the life cycle of a medical device and it's purpose is to address risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, software, and usability.

A multidisciplinary approach is essential to manage the Implementation and application of ISO 14971 since it requires input from various team members to cover all areas related to the safety of a medical device.

601 Consultancy Ltd is well equipped to guide your team and participate in the implementation and application of ISO 14971 to your medical device and assist you on an ongoing basis to ensure that your device meets the requirements of the standard including issues arising after the device is made available in the market.