– For medical device companies that have developed and delivered software to the market prior to the publication of IEC 62304, retrospective software validation can be both challenging and time consuming.
We support companies in making the transition to IEC 62304 compliance, in alignment with regulatory expectations and without unnecessary extra work.
– Product development
– Compliance and productivity improvements
Software validation for regulated processes
– Quality related
– Research and development
Application of risk management in information technology (IT) networks incorporating medical devices
– IEC 80001-1 and the recently published IEC 82304-1
Contact me for further information Robert Ginsberg
Office +46 8 621 01 05 or send me an mail