Tag: medical devices

Software Happens – A Challenge for the 21st Century

“My toaster says it’s “downloading a firmware update. Please wait…” What is a firmware update and why does a toaster need one? And, why is my toaster talking to me in the first place? All I want is a lousy piece of toast!!!” We were startled years ago to find that every day appliances like washing machines, refrigerators, and even toasters contained microprocessors… What do you think? Will software safety and reliability be the driving factors in product engineering in the 21st century? Continue reading

Posted in Complexity & Compliance Standards, Functional Safety, Integrity, Software Product Lines, Systems Engineering | Tagged , , , , , , , , | 1 Comment

One Size Does Not Fit All in Risk Management

Risk Management is a critical process in developing safe and effective medical devices as well as a requirement for regulatory approval. However, there is no single best method for managing risk that can be applied in all circumstances. Organizations often need to adapt… Continue reading

Posted in Integrity, Requirements Management, Risk Management | Tagged , , , , | Leave a comment

Isolated Risk Management is not Effective Risk Management

Risk Management is an essential requirement for compliance to the European Union and FDA Medical Device regulations. Standards-developing agencies have also focused on the importance of applying Risk Management to medical devices in view of ensuring patient safety, most notably in the ISO 14971 standard… Continue reading

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