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En titt i NMAs utbildningsprogram för hösten avslöjar bla en spännande kurs för mjukvaruutvecklare inom det medicintekniska området, 14 - 15 sepember:

“The course details the software validation requirements that need to be addressed during design control [21CFR Part 820.30(g)] and [§7.3 of the EN ISO 13485] for software developments.
There will be sessions on software risk management, development life-cycle, architecture, design, software verification and validation.
Software validation of proprietary medical device products, subcontracted and off-the-shelf software will also be covered.
Incorporation of EN ISO 14971, Medical devices - Risk management - Application of risk management to medical devices and AAMI /TIR 32 Medical device software risk management into the software life-cycle processes will be shown. And references to the coming guideline IEC/TR 80002-1 “Medical device software - Guideline on the application of ISO 14971 to medical device software”
All current documentation of the FDA and EU software regulatory requirements will be included in the course binder.
The format will include lectures, discussions groups and case studies.”

Intresserad? Förhandsanmäl dig till info(at)nordicmedicaladvisor.se

Tags: 14971, 21CFR Part 820.30(g), AAMI /TIR 32, CE, Design Control, EU, FDA, ISO 13485, IT, medical device, medical device software, medicinteknik, mjukvara, mjukvaruvalidering, NMA, Software validation, Utbildning, utbildningsprogram

Det här inlägget skrevs tisdag, 25 maj, 2010 klockan 9:00 f m i kategorin Dental, Kvalitetsledning, Medicintekniska branschen, NMA, Regulatory Affairs, Utbildning. Följ gärna kommentarerna på inlägget via RSS 2.0. Det vore roligt om du skrev en kommentar, eller gör en trackback från din sajt.