ISO 13485 & FDA 21 CFR Part 820 Compliance

White Paper Describes How ISO 13485 and 21 CFR Part 820 Provide a Framework for Compliance for Meeting Medical Device Quality Standards

Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of FDA's 21 CFR Part 820 and ISO 13485 international standard is to ensure medical device quality and safety and to reduce, if not prevent, injuries and deaths.

21 CFR Part 820 outlines Quality System Regulations (QSR) for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the international market.

	QA Download: Compliance for ISO 13485 & 21 CFR Part 820 Med Device

Watch Customer Video Using MasterControl for ISO Certification (2:17) Using MasterControl for FDA Compliance (3:53) How MasterControl Makes Your Job Easier (3:50)

MasterControl Inc., the pioneer in developing quality management software for companies in FDA and ISO environments, prepared this question-and-answer article to help medical device companies understand 21 CFR Part 820 and ISO 13485. The Q&A includes excerpts from the regulation and the standard, and specific MasterControl? features and modules that are relevant to such requirements.