SYS-CON MEDIA Authors: Scott Bampton, Greg Ness, Elizabeth White, Glenn Rossman, Pat Romanski

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Research and Markets: Medical Device Software Seminar: FDA Guidance & Risk Management - 15th October 2014, London, UK

Research and Markets (http://www.researchandmarkets.com/research/fbd9gk/medical_device) has announced the addition of the "Medical Device Software: FDA Guidance & Risk Management (Seminar, London)" conference to their offering.

15 October 2014 - The Rembrandt Hotel, London

This course is aimed towards delegates who have experience with Medical Device Software and wish to gain a better understanding of the complexities involved. It will focus on practical Risk Management and Usability Risk and will look in detail at the FDA guidance on Medical Device Software compared with the MDD guidance. Software recalls will be discussed, the use of apps in medical devices as well as the implications of the new draft Usability Standard. Practical advice on how to validate your system design will also be addressed. The seminar will be beneficial to attend as a follow on from the Introductory course held on 15 October 2014.

PROGRAMMER INCLUDE:

- IMDRF on Software as a Medical Device (SaMD)

- The Future European Medical Device Regulation and the Impact on Manufacturers of Medical Software

- First Edition of IEC 82304

- Second Edition of IEC 62304 and IEC 62366

- IEC 14971 and the Commission's Alleged Deviations Against the Essential Principles

- IEC 14971 and Software

- FDA Guidance on Medical Device Software

- FDA vs MDD

WHO SHOULD ATTEND

- Senior Management, Project Leaders

- Internal/External Auditors and/or Consultants

- Regulatory Affairs

- Quality Systems and Quality Assurance Personnel

- IT Managers

- New Product Development, Marketing

- Software Product and Process/Manufacturing Engineering Staff

- Document Control/User Manual Writers

- R&D Software Engineering Team Members and GUI Designers

For more information visit http://www.researchandmarkets.com/research/fbd9gk/medical_device

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