On December 18 of 2019, The International Organization for Standardization (ISO) presented their new and improved guidelines on medical devices ISO 14971, . The document instructs on the process of risk management for medical devices such as, software as medical devices, in-vitro diagnostic devices and other products which might defer medical devices classification under some jurisdictions.
New process to Help Manufacturers:
The new process is intended to help manufacturers to identify any hazards related to their devices and provide an estimated evaluation guide on the various risk involved like that of; bio-compatibility, data and systems security, electricity, moving parts, radiation, and usability etc and how they plan on addressing them, providing mitigation strategies and controlling such risk factors.
Furthermore, the requirement to disclose such risks have been merged into one requirement and the overall residual risk shall be first well evaluated and then accepted to be put through, each of which needs to be well defined in the risk management plan as stated above.
Details on Data
It also mentions details on the data “to be gathered and the actions to be taken” when the collected data has been investigated and resolved to be applicable.
This incorporates survey of risk management and assurance if (re)- assessment of (new) risk is important, analysis of effect on previous risk control, actions for devices already commercialized and their results to act as input to review the suitability of risk management process.
ISO has also revised the production and post-production activities, which would help in defining the policies for nation-wise risk of a product and providing a guided protocol on risk acceptability regulations along with establishment of risk management plan which needs to be reported prior to commercial distribution, intending at the use of reviewed data and literature for similar marketed devices.
The ISO standards believe in providing a streamlined arena for the product manufacturers to promote standardization of operations at a global level.
ISO 13485-. Quality Management for Medical Device