News about GMP/cGMP


FDA approves new ISO Standard 14971:2019 for medical devices

In December 2019, the International Organization for Standardization (ISO) published the revised standard ISO 14971:2019 on application of risk management to medical devices. This standard has now been added to the list of Recognized Consensus Standards by the US FDA.


What's new in brief:

The 36-page ISO standard with its new chapter structure, introduces the definition of the term "benefit" or defines the term "state of the art", which is to be used as a cornerstone. For senior management, it accordingly sets out what the risk policy in the company should look like. ISO 14971 requires manufacturers to assess residual risks according to defined acceptance criteria. A "reasonable forseeable misuse" should also be analysed in advance, as well as the security and safety risks within the IT systems. Increased need for action arises not only for risk management during the production phase, but also for the phase that follows production, the so-called "post-market phase". These requirements are clearly based on the new MDR.


ISO Online Browsing Platform: Application of risk management to medical devices