Medical Device Software Validation

       All the manufacturers supplying medical devices to the U.S. are required to maintain a quality management systemin compliance with the FDA 21 CFR Part 820.   This quality system regulation focuses on current good manufacturing processes and controls used for the design, manufacture, packaging, labelling, storage, installation, servicing for all the medical devices. 21 CFR Part 820 lays out the essential elements that a quality system shall embody, without describing specific ways to establish them, as the requirements must apply to a broad spectrum of medical devices. Thus, the manufacturer must develop a quality system that commensurate with the risk presented by their device, complexity of the device and manufacturing process, extent of the activities to be carried out and size and complexity of the manufacturer. The medical device manufacturers undergo USFDA inspections, to ensure compliance to 21 CFR Part 820, however, there is no certification m...

  One of the important requirements of the medical device regulations is the documentation and maintenance of a systematic procedure to document performance and safety of medical devices once in the market. The requirements and the need for implementation of post-market surveillance system is outlined in various standards and regulations including EU MDR, MDD, MEDDEV, ISO 13485, ISO 14971 and US FDA among other guidelines. Post-market surveillance work has usually been dismissed by medical device makers. However, regulatory bodies globally are to implement additional rigorous needs for post-market surveillance work requiring medical device manufacturers to take action to stay compliant. Regulatory bodies are encouraging manufacturers to take up proactive approaches instead of relying solely on reactive systems, like complaints observation. Post market surveillance as defined by EU regulations is to proactively collect and review experience gained from devices placed on the mar...

  Medical devices marketedin the US market are subject to the regulatory controls ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act) and additionally the laws in Title 21 - Code of Federal laws (21 CFR) elements 1-58, 800-1299. The regulatory controls and commerce pathwayshelp assess the risk posed bythe device and are needed for assurance of safety and effectiveness of the medical devices. The regulatory pathways include: Premarket Notification (510(k)), Novo Classification Request, Exempt, Premarket Approval (PMA), development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA). Broadly, the steps to bring a device to the market can be covered in three steps: 1.         Classify the device 2.         Select the appropriate regulatory pathway 3.         Establishment registration and device listing Classification of devices...