2024年11月21日 · On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align...

2024年1月31日 · Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated...

§ 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

2023年12月19日 · What is a medical device Quality Management System (QMS)? A Quality Management System, or QMS, is a comprehensive framework, or set of documented procedures, that guides people in an organisation to consistently deliver products that meet customer and regulatory requirements.

2023年3月28日 · Medical Device Quality Systems Manual: A Small Entity Compliance Guide. The FDA Worldwide Quality System Requirements Guidebook for Medical Devices. Other device specific guidance...

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

2023年11月30日 · In simple terms, a medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.

2025年1月27日 · The ISO 13485- Medical devices- Quality management system- for regulatory purposes is an international standard developed by a recognized international standard body- International Organization for Standardization (ISO) first in 2003 with the latest version released in 2016. It is written to specify requirements for an organization to design ...

2025年1月24日 · A Medical Device Quality Management System (QMS) is a structured system that documents the procedures and processes implemented throughout the lifecycle of a medical device. A medical device QMS is essential to ensure quality in developing, manufacturing, and distributing processes.

ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy. Why is ISO 13485 important?