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ISO 13485 Standards

Get free white papers and learn from industry practitioners and experts on how ISO 13485 Standards Provide the Framework for medical device compliance internationally. ISO 13485 standards are a group of international standards for medical device manufacturers. The main goal of the ISO 13485 standards is to provide a harmonized model for quality management system requirements in the international market. (Note that ISO 13485 2003 has replaced ISO 13485 1996.)

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Educational Materials

Get insider information about the most relevant issues in ISO 13485 today, and how to navigate and overcome the complexities of FDA and ISO compliance.

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White Papers
  • This white paper provides a concise overview of ISO 13485 and examines how obtaining certification to the standard can open doors to untapped domestic and international business opportunities. It also explains how to avoid becoming one of the 50 percent of device companies that fail to obtain recertification due to inadequate manual processes.
  • Since the majority of medical device manufacturers must comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 quality management system (QMS). This white paper delineates the intersection points of these regulatory requirements and provides valuable information about document naming and numbering strategies for enhanced compliance.
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  • This webinar is Part 2 of the ISO 13485:2016 webinar series. It addresses the universal changes in this regulation and how to implement them.
  • This webinar is Part 3 of the ISO 13485:2016 webinar series. It addresses the universal changes in this regulation and how to implement them.

Educational Materials

  • Since 2000, we have benefited from a technology-driven era in regulatory compliance. This e-book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

Product Information

Discover how MasterControl ISO 13485 can manage your quality process, all while mitigating risk, improving speed-to-market, and generating ROI.

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  • What do you need to know about compliance with 21 CFR 820 and ISO 13485? This informative question and answer summary explains what these standards are, who they cover, their relationship to each other, and much more.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your ISO 13485 program.

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Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
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The preferred method for proving conformity is the certification of the Quality Management System according to ISO 9001 2000 and/or ISO 13485 standards, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). A positive assessment is needed for authorization of the CE-identification and the permission to sell a medical device in the European Union.

Why is Compliance to ISO 13485 Standards Important in the U.S.?

Although in the U.S. ISO 13485 Standards, compliance is voluntary, it provides a framework for meeting medical device quality requirements in the international market. Compliance with ISO 13485 standards also helps meet the requirements specified in 21 CFR Part 820 for the Quality System Regulations (QSR) applicable to medical device manufacturers and importers.

How can Automation Facilitate Compliance to ISO 13485 Standards?

Through efficient process management, medical device companies can achieve increased efficiency, higher performance, and reduce their operational costs. Transforming manual processes into automated processes in areas such a document control and process management can provide dramatic results in terms of assuring compliance to ISO 13485 standards.

Why is Compliance to ISO 13485 Standards Important in Europe?

ISO 13485 outlines the requirements for a comprehensive management system for the design and manufacture of medical devices. Compliance with ISO 13485 standards is often seen as the first step in complying with European regulatory requirements. The conformity of medical devices, as well as in vitro diagnostic devices, must be assessed before the sale of the medical device can commence (see EEC Decrees 93/42/EEC, 90/385/EED and 98/79/EEC).

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