Information on ISO/IEC 12207 and other software engineering standards

For key FDA, IEC and ISO standards including IEC Standard 62304:2006. Checklists clarify what is really required for compliance through a product evidence list that assists software organizations in meeting the requirements of the standard. The checklists are constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews. Each checklist comes with 4 hours of consultation.

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