Speakers:

  • Molly Story
    Human Factors and Accessible Medical Technology Specialist, Office of Device Evaluation, Center for Devices and Radiological Health
    FDA (via video conference)
  • Ed Israelski
    Director Human Factors
    Abbott
  • Paivi Roiha
    Regulatory Affairs Leaders
    GE Healthcare
  • Markus Nagel
    Director of Quality Management
    Siemens Healthcare

Ensuring Compliance to Evolving Regulations and Standards whilst Incorporating Quality & Usability into Agile Design

Are you compliant with the upcoming 3rd edition of IEC 60601 in June? Are your processes Agile, and are those that are Agile really as Agile as they could be? Do you incorporate human factors into your software design? Are those processes compliant with the FDA’s new draft guidelines on usability in medical devices?

These are the sort of questions that the most clued-up software engineers and project leaders are asking themselves, which is why they are planning to attend Software Design for Medical Devices Europe 2012 (or SDMD 2012 for short) - the only pan-European and English-language conference that is dedicated to the important area of software design in the Medical Device industry.

The event addresses key issues in the development and regulation of medical device software, including:

  • Building more effective usability/human factors methodologies into software development
    Learn from world leaders in usability such as Ed Israelski, Director Human Factors at Abbott, plus hear from the FDA on their usability guidelines and expectations in medical devices via our exclusive interactive video-link during the event!
  • Making your development processes more agile, and improving your agile standards compliance
    Hear case studies on implementing Agile methodologies such as Scrum in a software development life cycle from Given Imaging and Flextronics
  • Getting the latest regulatory updates from the perspective of the Notified Bodies – how does their interpretation of the standards such as IEC 62304 differ from yours? What do they expect?
    Quiz Underwriters Laboratories, BSI/Eurocat and TÜV Sud on what their interpretations of 62304 are, the upcoming 3rd edition of 60601, auditing processes and generally any other questions you have!

With the success of the long-running SDMD conferences in San Diego and Philadelphia, as well as the first ever European summit earlier this year, this event is not-to-be-missed. Register your place now, and See you in Munich!


pod_newgg Tips for Medical Device Manufacturers to Prepare for the Revised 60601 - by Werner Kexel

Discuss the 3rd revision to the standards guideline 60601 and tips for medical device manufacturers on how to prepare for the changes!



Testimonials

What People Have Said about Software Design for Medical Devices Europe

"Highly valuable"
Renishaw
"Valuable for getting a view on the problems from different angles, and for making contacts with experts in this area"
Institute for Testing and Certification
"I’m looking forward to sharing best practices, improving my network and learning from other experts and my peers."
Siemens Healthcare
"I look forward to attending Software Design for Medical Devices not only because I will hear about current developments and trends, but will have the chance to exchange ideas and information with colleagues who are facing the same challenges as I am, every day."
ShoeBar Associates
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