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FDA/ISO Compliance Toolkit

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1 Toolkit FDA/ISO Compliance Toolkit In August of 2018, the U.S. Food and Drug Administration (FDA) announced its intentions to use ISO (International Organization for Standardization) 13485:2016 as the basis for its quality system regulation for medical devices. Part of the FDA's motivation in this measure is to harmonize global medical device regulation. To achieve compliance with the new requirements and better align with evolving industry trends, medical device manufacturers are recognizing the value of moving to a digital quality management system. The 2016 version of ISO 13485 contains information and guidelines that apply specifically to medical device development, such as design control, risk mitigation, and supply chain management. This toolkit includes white papers, videos, and other resources that provide valuable insight about ISO 13485, the FDA's expectations for compliance, and how using quality management technology is critical to ensuring quality in medical device manufacturing. White Papers • Automating Document Control Processes FDA regulations require all companies that manufacture regulated products to have a document change control system. This white paper provides useful tips for improving efficiency and ensuring compliance with document control processes throughout the product development lifecycle. • ISO 13485 – Change? Do I Have To? The ISO 13485:2016 standard underscores the importance of medical device manufacturers applying a risk-based approach to quality management, which extends to outsourcing and supplier management processes. This white paper highlights the primary requirements of 13485:2016 and provides tips for achieving compliance with the standard. • 21 CFR Part 11 Industry Overview: Ready for an FDA Inspection? 21 CFR Part 11 applies to all FDA-regulated companies using electronic records and electronic signatures. A vital aspect of the regulation is data integrity. All electronic records surrounding regulated products should be accurate and valid. This white paper addresses how using an electronic quality management system (QMS), such as MasterControl, is valuable for complying with 21 CFR Part 11 and maintaining inspection readiness.

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