18 Sep Production and Post-production Requirements in the New ISO 14971
The third version of ISO 14971 is currently being published. The new version of ISO 14971 is set for release in Q4 of 2019. Read our blog NEW REVISION OF ISO 14971 COMING SOON.
The clause on production and post-production requirements has undergone considerable modifications. The additional steps that medical device manufacturers will have to take are:1
- Plan and establish a system to collect and review production and post-production data. This includes collection, review, and processing of data with appropriate statistical techniques and trend analysis. This system may also be integrated with complaint handling and other post-market surveillance system to generate dynamic data. The established system to do so must be included in the risk management plan.
- After you have established a system, collect the relevant information or data. The data may come from multiple sources. A list of sources is included in the standard, some of them are data from complaints, post-market surveillance data, supply chain, information available about the predicate device. The aim is to have manufacturers actively obtain data rather than passively wait for the data to be available.
- Next step is to review the information obtained from all the data sources. The analysis must be focused on determining if any previously identified hazards or hazardous situation still exists and the risk control measures applied were not effective. Any residual risks previously identified can be mitigated now or that it is no longer acceptable and if the risk-benefit analysis is still acceptable.
- Appropriate analysis and data trends will help manufacturers take the necessary action. Whether those actions are to implement additional risk control measures or actions regarding medical devices in the field. This data analysis provides valuable input for management to review the suitability of the risk management process for the organization.
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1BSI (Sept 2019) Production, post-production and the new ISO 14971 retrieved on 09/12/2019 from https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/production-post-production-and-the-new-iso-14971/?utm_source=pardot&utm_medium=email&utm_campaign=SM-SUB-LG-HLTH-CN_blog-2019