This standard requires manufacturers of medical devices to identify the hazards associated with the medical device that are being manufactured or if the organization is in the planning phases, to estimate and evaluate the associated risks, control the risks outlined, and to monitor the effectiveness of those controls.
The requirements of this standard are applicable to all phases of the life cycle of a medical device and do not require the manufacturer to have a quality management system in place. The processes outlined are applicable to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
Certificates of conformance are issued on an annual basis and are a good starting point for manufacturers’ who are thinking of entering the ISO 13485:2016 scheme. For clients wishing to upgrade or to certify to ISO 13485:2016, ISO 14971:2019 is often the first step within an organization’s management system plan. We also offer Gap Assessments for ISO 14971.