Simplicity and ease-of-use in Risk Management
Based on the regulatory requirements on Safety Risk Management, the medical device industry invested a considerable amount of time and efforts to generate and maintain risk management documentation. We should now be ready for the next step, to turn these investments into value adding tools and to make them easier-to-use for engineers. This presentation will show how to simplify risk management and how to use the information more effectively while carefully avoiding overloaded and non-sustainable quality systems.
Templates for Safety Risk Management
The attached templates may be used for Risk Management activities. Trainings are available for including workshops.
ISO 14971:2019
As a quality practitioner in medical devices I was heavily looking forward to the 3rd edition of ISO 14971 - Application of risk management to medical devices. In a time of deep regulatory changes (ISO 13485:2016, European MDR and IVDR, MDSAP) there was a threat of another big game changer on the horizon. The recent publication of the ISO 14971:2019 however, shows that the technical committee was probably very aware of the current work load in medical device industries and did, that’s my first opinion, quite a good job. There are not too many changes to the standard and some improvements were made. Accordingly I revised the templates on my webpage to the new version of the standard.
Harms and severities - applying IMDRF and CTCAE
Manufacturers sometimes struggle to determine adequate medical terms and to assign reasonable severity ratings as required by ISO 14971. In the past there was very limited guidance available discussing this task. In the meanwhile there were some helpful documents published making the challenge a bit easier and much more transparent. I want to remind you of IMDRF guidance on terminologies for adverse events and CTCAE Common Terminology Criteria for Adverse Events. Both fit together really well, see my article attached.
Risk management for suppliers
Safety risk management as per ISO 14971:2019 aims to protect patients and users from harm caused by medical devices. Over the last two decades, medical device manufactures got used to this standard and are more or less compliant to its requirements. However, many supplier are challenged by implementing the requirements of ISO 14971 in their quality systems. Being scrutinized by customers and/or certification bodies, suppliers are struggling to get access to the medical and technical information needed to conduct proper risk management. Consequently, not knowing the details about the technologies and usage of the final medical devices, not having access to the PMS data needed and not being involved in the clinical evaluation and benefits, suppliers often implement insufficient risk management documentation just for the sake of satisfying their customers and their auditors. It is obvious, that such situation unfortunately leads to frustration and a limited acceptance of risk management principles. A supplemental risk management plan for suppliers may help adressing this issue.
Attached files:
Template Risk Analysis (FTA type)
Template Risk Analysis (HA-FMEA type)
Simplicity and ease-of-use in Risk Management
Combining FMEA and HACCP
Risk Management File 2019
Risk management Plan 2019
Risk Management report 2019
Harms and severities - applying IMRF and CTCAE
supplemental Risk management Plan for suppliers
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