From ISO 14971:“FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an inductive technique using the question “What happens if?”. Components are analysed one at a time, thus generally looking at a single-fault condition.
StandardsBasically, this template deals with ISO 14971 and sections about risk management of IEC 62304. Use it to answer to those requirements of these standards. During design and after designRisk assessment doesn't stop after design. I usually split risks in 3 categories:. Risks linked to the device itself: its intended use, its characteristics affecting the safety,.
Each hazard associated with any aspect of the medical device is evaluated and placed in one of the risk-matrix cells. That the worm may be of Western origin and that it was able to infect multiple nuclear industrial sites in Iran.3 We may determine in the subsequent steps of the analysis that such a threat has very low likelihood for the. Safety Data Sheets. A Safety Data Sheet (SDS) provides data regarding the properties of medical device products. Almost all Fresenius Kabi medical devices are non-hazardous and therefore do not require SDS sheets. However, the few products for which an SDS is required are made available here in PDF format.
Risks linked to the design process,. Risks linked to other processes after design.These risks are essentially mitigated by the quality management system of the company. Risks linked to the design processExamples of risks are: wrong design, buggey tools used for design.Procedures, like Design procedure and forms, aim at defining a structured design process.This is the main goal of all templates I've published: to mitigate risks of having a bad design process.However, even if the design process is correct, the tools used for design shall be verifed. This is a subset of risks in design process: the risks of having bad tools for design (imagine the consequences of a 'buggey' bug repository). I will address these very specific risks in a further post. Risks linked to the device itselfProcedures, forms (like the risk management plan and the ) aim at identifying and mitigating risks linked to the device.I address these kind of risks in the first part of my risk management plan. Risks linked to other processes after designThe second part of my risk management plan addresses the maintenance of the risk analysis report after design.
![Medical Device Hazard Analysis Template .xls Medical Device Hazard Analysis Template .xls](/uploads/1/2/5/6/125633069/449087795.jpg)
This is classical in risk management, but this second part contains an additional section.Procedures and forms, like Production, Delivery, CAPA, post-market surveillance, address risks after design.However, you may have risks specific to a device or a family of devices, which may require mitigation actions after design. For example, You may sell a software with customer input data different from those required by your other software. These input data may require a verification step before selling the software.This subset of risks after design are addressed by the last section of the second part of my risk management plan. RecipeI'd like to add a last word about this template. Like any other templates of my own, this is a cooking recipe. And like any cooking recipe, the final result may not be as delicious as what is on the photo in the cook book. If you're specialized in software, don't try to fill this template without the help of someone who is experienced in risk assessment.You, developer, know how it is easy to write ugly code without coding experience.
That's the same for risk assessment!Stay tuned, my list of templates is growing fast!I gather all my templates on the. You'll find them all there.Please, fell free to give me feedback on my e-mail [email protected] share this template with the conditions of.This work is licensed under a.