2013 International Speakers include
Europe’s Only International, English-Language Software Design Focused Forum For Medical Device Manufacturers
International risk management standard ISO 14971 has been called into question by the European Commission on the grounds of non-compliance with the Medical Device Directive. 60601-1 has had a 3rd revision deemed sometimes so vague that a complimentary document - IEC 62348 – was created to ease the transition, and both 62304 and 62366 are due EU and FDA updates in the next 12 months – it's a wonder anyone manages to stay compliant at all!
Not to worry though, as some individuals from medical device companies put themselves in the line of fire to try to ensure that new standards are logical, thorough and accessible. People like Chuck Sidebottom at Medtronic, or Dave Osborn at Philips, or Ed Israelski at Abbott Labs – and we are very excited to bring them all together at the 3rd Annual SDMD Europe in January 2013.
With a new, in-depth look into compliance and quality issues, as well as the usual popular topics of agile programming methods, new testing/V&V techniques and product usability, international medical device company QA-RA and software professionals have a real must-attend date in the calendar - the only truly international and English-language software development and compliance forum dedicated to medical devices.
So What's So Great About SDMD Europe 2013?
- Get the latest updates and stay compliant with ISO/IEC standards 60601 3rd revision, 62304 software, 62366 usability and 14971 risk management; interactive Q&A and discussions led by group conveners and regulators
- Become more agile and discover how to move away from hybrid models in safety-critical application with key sessions from Texas Instruments, Elekta and Lean-Agile Partners, along with a full-day agile training course
- Improve the usability and quality of your product with expert insights from Ed Israelski, Director of Human Factors at Abbott Labs and Molly Story from the FDA
- Increase the efficiency of the product software lifecycle with the latest safety testing techniques, version tracking and effective documentation; led by Given Imaging and Elekta
See you in Munich!
Who Will You Meet?
This event will be attended by:
- Software Development Managers
- QA/RA (Quality and Regulatory)
- Software Managers & Engineers
- Heads of Software Development
- Software Architects
- Project Managers
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