Books / Literature: Risk Management for Medical Device Software recommendations

Hey Everyone,

thanks again for a splendid forum!

I´m a newbie within the Risk Management & Quality Assurance area and I´m also working in a newly started company (with very limited collected experience within risk management and quality assurance among our co-workers).

We have gained our certification for the CE-mark (Europe) so we do know ONE way to implement the standards, perform risk management and develop our processes.

However, I feel the urge to improve my general knowledge and awareness within these areas in order to improve our work!

Does anyone have any recommendations to literature or books to read to improve the work, implementation and thinking around these issues?

THANKS!

Re: Books / Literature: Risk Management for Medical Device Software

Hello, there is a lot of information here at the Cove regarding the subject matters you mention, feel free to look around and ask any question you may have, here's a good starting point regarding Risk Management: ***Search Link Fixed*** Risk Management

Re: Books / Literature: Risk Management for Medical Device Software

The only book i know on the subject has been published recently - The Medical Device Industry: Developments in Software Risk Management (although, seeing the contents in Amazon, i didnt like the book very much because´it seems to focus too much on the software engineering aspect and does not seem to take into account the regulated aspect).

The other book on medical device software is "Safe and Sound Software: Creating an Efficient and Effective Quality System for Software Medical Device Organizations" (which, as the name implies, is more related to quality systems, although having a risk management chapter).

But, from your inquiry, you seem to need a more practical approach, and in this case, i would suggest you read two standards on software risk management:

AAMI TIR32:2004, Medical device software risk management

IEC TR 80002, Medical device software – Guidance on the application of ISO 14971 to medical device software

Re: Books / Literature: Risk Management for Medical Device Software

Thanks alot for your input!

Any idea from where I can get the IEC TR 80002?

Thanks!

Re: Books / Literature: Risk Management for Medical Device Software

The IEC website says that IEC/TR 80002-1 Ed. 1.0 should be available in Dec-2009