Software Medical Devices - I need to go to Boot Camp!

[echo7tango]

I've worked in software development for 20+ years and am now relatively new to Quality Assurance. While I have a lot of OJT (on-the-job training) in an FDA-regulated environment, I now seek formal training and certifications. OJT works well enough, but I want a good foundation of formal training.

Can you point me to good resources or classes?

My field is Software Medical Devices, with a focus on software medical device (and non-device) processes, so I know I need ISO 14971, ISO 13485 and ISO 62304; also, will need auditing skills and techniques. I prefer a course curriculum from one provider that builds first on the basics and then into "the finer points", for want of a better description. I also much prefer in-person classes, instead of webinars.

I will need 62304 quickly (!), because I have a current assignment for a product gap analysis and plan to implement conformance.

Thanks much!

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[sagai]

Difficult stuff is the one you are asking, because you are looking for software development specific training courses in the context of medical devices.
To be honest ... I have found almost none really useful.

For ISO14971 there is an AMMI technical report particularly for software. That is the good stuff to go through.
Also for process software validation, there is an AMMI report to read.

For ISO13485 ... actually however there is a kind of internal auditor training and also a Lead Auditor training, those are general purpose trainings and not really answering your questions for software development.
To be honest ... even auditors are just looking and learning many cases when doing there scheduled audit on a software development company premises. May be it is my problem, but I can not recall any ISO audit, when the development activity received any valuable feedback from auditors.

In general I would go for a Lead auditor certificate for ISO9001, I have found that one useful, plus there is a standard based on ISO9001 for software companies to adjust your knowledge.

I think there should be a training on IEC62304, however I would expect an experience based training rather than a walk through review as most of the training is about.
But IEC62304 neither guarantees nor ensures any success on audits.

For cGMP, I would suggest to go through the guidances that FDA provide. Good stuff actually, however several read needed to get the flavor of those.

That would be the one I can suggest, Cheers!

 

[echo7tango]

Thanks, sagai, I'll look into those.