![]() ![]() The scope of the document is to assist medical device manufacturers in identifying the hazards associated with their medical device, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls through design, production, and post-production phases to ensure patient safety throughout the duration of a product lifecycle. The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. ![]() This column will summarize the basic concepts of ISO 14971, highlight the main changes that were made to the document, and provide guidance on what to focus on when evaluating and documenting a medical device for its potential risks. ![]() Earlier this year, a final draft of the new ISO 14971: Medical devices- Application of risk management to medical devices came out for voting, and will soon be published as a revised document that will replace the current second edition of the document (ISO 14971:2007). ![]()
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