The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries. Greater alignment of FDA Quality System Regulation( QSR) with ISO 13485, first proposed by the regulator in May 2018, would bring US QMS conditions for medical device manufacturers closer in line with quality system conditions in markets similar as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets. What's ISO 13485 Quality Management System How do you manage your Quality Management System? If you're like the majority of the medical device industry, chances are you have a QMS that's a combination of paper- based processes and general purpose tools, approximately held together by a group of people within your company-- generally document control. It’s important because it's long overdue with the former interpretation being released 13 years before in 2003. The 2016 standard is veritably much a bridge. What I mean is that this bridge explicitly describes and defines current QMS prospects for medical device companies. Prior to these advances being formally defined and documented in the standard, numerous of the best practices being advised and adopted were veritably ad hoc in nature and frequently sounded to be based on auditor opinions. Medical device manufacturer should appoint an experienced ISO 13485 consultant who can work on all risk class devices. The associations need to cover the safety and risk information during product life cycle as per ISO 13485 demand. As an ISO 13485 medical device consultant, Operon Strategist identify the specific regulatory demand for the product similar as MDR, FDA 510( k) during the perpetration. This helps manufacturer in the further process of CE mark medical device or FDA 510( k) clearance. An Overview of the ISO 13485 Quality Manual for Life Sciences The International Organization for Standardization( ISO) is an internal standard- setting group of representatives from public standards associations. This group maintains a comprehensive set of standards for life sciences associations. These standards are generally referred to as ISO 13485 standards. The current version of ISO 13485( last streamlined in 2020) sets forth major manufacturing and quality guidelines for businesses in largely regulated industries. To alleviate unforeseen danger and uphold universal quality control standards across the medical device manufacturing industry, an ISO 13485 quality homemade outlines the mission-critical quality control guidelines and QMS conditions needed to keep both users and manufacturers safe. https://operonstrategist.com/services/turnkey-project/quality-management-system/iso-13485/?utm_source=Article+Submission&utm_medium=Off+page1&utm_campaign=Article+Submission