In other words, a medical device company focused on U.S. In contrast to ISO 13485:2016, FDA 21 CFR Part 820 Quality System Regulations is the law for medical device companies manufacturing and selling products for the U.S. Risk management and risk-based decision making processes have become a focal point of the entire medical device industry (at both the QMS and product levels).The medical device regulatory environment has evolved quite a bit since 2003.Let me simply summarize why by providing two basic reasons: There are several reasons for why ISO 13485 was finally revised earlier in 2016. Achieving ISO 13485 certification is assurance that a company meets certain quality management system expectations defined within the standard. Because of this, adhering to ISO 13485 is an accepted approach with regulators.

And remember that this standard has been authored and influenced by the major medical device regulatory bodies across the world. Doing so helps a company address medical device product safety and overall effectiveness. The premise of ISO 13485 is that of continuous process improvements. Adhering to ISO 13485 improves the likelihood that a medical device company will meet customer and regulatory requirements. While adherence to ISO 13485 is not explicitly required, there are several benefits of doing so. ISO 13485 does not define business requirements (such as financial requirements).īonus Resource: Click here to download your free PDF of the full comparison table of ISO 13485:2016 vs.ISO 13485 does not define specific requirements for a company’s products and services.ISO 13485 is a voluntary standard and technically is not a required structure for a quality management system.ISO 13485 is internationally agreed upon and defines a way to address common regulatory concepts.ISO 13485 evolved out of the general quality management system standard ISO 9001 and is specific to medical device industry.Without going through an entire history lesson of the evolution of ISO 13485, know this: Maybe most importantly, how does ISO 13485:2016 align with FDA 21 CFR Part 820 ? Why is this new version of ISO 13485 so significant?Īnd what does this mean for your quest to have a quality management system to meet all of the major global medical device quality system regulatory requirements? The last major revision of this quality management system standard happened back in 2003. The publication and release of ISO 13485:2016 earlier this year is a significant movement for the medical device industry.

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