The new version of IEC 60601-1 (3rd edition, 2005) replaces IEC 60601-1-4, not just ISO 14971. IEC 60601-1-4 includes both risk management requirements and PEMS development process requirements. IEC 60601-1-4 remains a harmonized standard in the EU to meet the essential requirement of the MDD on PEMS, if the 2nd edition of IEC 60601-1 is...Read More
This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Crimson Life Sciences which performs language translations for labeling and user interfaces was assessed by Underwriters Laboratory for conformance with the ISO 14971 Medical Device Risk Management standard. The summary of the audit results is available at this link...Read More
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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.