Your distinguished speaker faculty includes:

  • RichardRichard C. Chapman
    General Engineer, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories, Centre for Devices and Radiological
    U.S. Food and Drug Administration (FDA)
  • dirkDirk Wetzel
    Head of Medical Devices Division
    BfArM
  • steveSteve McRoberts
    Global Principal Engineer
    Underwriters Laboratories International
  • KeroKero van Gelder
    Software Engineer
    Philips Research Europe

View All Speakers

Ensuring Compliance to Evolving Regulatory Standards and Incorporating Quality and Efficiency into Design

Software Design for Medical Devices Europe is the only pan-European conference that focuses on the important area of software design in the Medical Device industry. The event will address the key issues in development, regulation and compliance including:

  • Adapting effectively to the 2010 changes to the EU Medical Device Directive to reduce the risk of compliance failure and streamline new submissions
  • Getting the latest updates from the perspective of the Notified Bodies, including TUV and Underwriters Laboratories - just how can you get your product on to the market quicker?
  • Hear from the FDA what precisely their expectations are in order to get approval and how their Guidance is changing, including their stance on IEC 62304 and 93/42/eec integration



European Exclusive!

With the success of the long-running Pharma IQ SDMD conferences in San Diego and Philadelphia, we are thrilled to be launching SDMD Europe “on the other side of the Pond” on the 19th - 21st January 2011 in Munich, Germany.

With a stellar line-up of expert speakers - including all 3 levels of certification and 93/42 and IEC 62304 guidance; Regulatory (the FDA), Competent Authority (BfArM) and Notified Body (Underwriters Laboratory) – SDMD Europe is truly a unique and exclusive opportunity not to be missed!

How will you effectively manage the amended MDD and other medical device regulations?

What Others Have Said about Pharma IQ Events

"Excellent. Very valuable!" Tracie Ward, Pfizer Ltd
"Great conference! Packed full of useful information" Process Development, Precision V&V
"All very interesting & well prepared speakers. Very useful & thought provoking." Sean Feeney, Elan Corp.
Sponsors Media Partners
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