Most Companies are Failing Their First IEC-60601-1 3rd Edition Submission
The 3rd edition updates to the standard IEC - 60601-1 are focused significantly around risk analysis, extending the application of ISO-14971 to clauses within 60601-1 itself, software under IEC-62304, and usability under IEC-62366. Both of these harmonized standards (IEC-62304, IEC-62366) are considered defacto proof of conformance to the essential requirements of the Medical Device Directive in Europe and similar requirements in the U.S. and other countries. The update also extended requirements for engineering documentation and process from system level to sub-systems within the product. Over 701 auditable clauses require the manufacturer to provide traceability of clause to document number and page for SOP’s, and in some cases, specific deliverables.
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