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Does anyone know of any really good Medical Device Software Training courses or Conferences?
Last month our engineering groups took a training course on IEC 62304 and even though we had arranged for the course to be held specifically for us, it covered QMS software validation too much. I am looking for something more specific to medical product development. The audience would be Software Engineering Management team members that are fairly new to FDA and ISO 13485 requirements.
I have already looked at many public course offerings from Stat A Matrix, UL, cfpa, AAMI and other well known training centers. I do not see a course that would address the nuts and bolts of medical device product software development for US and EUR markets including the documentation requirements. I need the Software Managers to understand the detailed documentation requirements. For example, when I ask them to supply a software tool validation report, they give me a 2 page document with some screen shots on it. They need to see real life cases or templates to understand the expectations.
Last month our engineering groups took a training course on IEC 62304 and even though we had arranged for the course to be held specifically for us, it covered QMS software validation too much. I am looking for something more specific to medical product development. The audience would be Software Engineering Management team members that are fairly new to FDA and ISO 13485 requirements.
I have already looked at many public course offerings from Stat A Matrix, UL, cfpa, AAMI and other well known training centers. I do not see a course that would address the nuts and bolts of medical device product software development for US and EUR markets including the documentation requirements. I need the Software Managers to understand the detailed documentation requirements. For example, when I ask them to supply a software tool validation report, they give me a 2 page document with some screen shots on it. They need to see real life cases or templates to understand the expectations.