An Introduction to Medical Device Software: Regulations & Requirements 2015 is a conference dedicated to EU & FDA Guidance and Risk Management.
Topics
2007/47/EC – Implications for Software
Medical Device Directive 93/42/EEC Published as Directive
Software and IEC 60601-1 Edition 3
Overview of Software and Medical Standards
Risk Management ISO 14971
Software Life Cycle Processes & IEC 62304:2006
Developing a Technical File for a Medical Software Project
Application of Usability Engineering to Medical Devices
IMDRF on Software as a Medical Device (SaMD)
Auditing a Software Project – Internal and External Auditing
On Manufacturers of Medical Software
The Future European Medical Device Regulation and the Impact
Second Edition of IEC 62304 and IEC 62366
First Edition of IEC 82304
Essential Principles
IEC 14971 and the Commission’s Alleged Deviations Against the
FDA Guidance on Medical Device Software
IEC 14971 and Software
FDA vs MDD
Who should Attend
Internal/ External Auditors and/or Consultants
Senior Management, Project Leaders
Quality Systems and Quality Assurance Personnel
Regulatory Affairs
New Product Development, Marketing Software Product and Process/Manufacturing Engineering Staff
IT Managers
R&D Software Engineering Team Members and GUI Designers
Document Control/User Manual Writers
Past Events
An Introduction to Medical Device Software: Regulations & Requirements 2015 - 20-21 May 2015, The Rembrandt Hotel, London, United Kingdom (49678)
Important
Please, check "An Introduction to Medical Device Software: Regulations & Requirements" official website for possible changes, before making any traveling arrangements
