An Introduction to Medical Device Software: Regulations & Requirements 2015 is a conference dedicated to EU & FDA Guidance and Risk Management.
An Introduction to Medical Device Software: Regulations & Requirements 2015 covers topics such as:
- 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
An Introduction to Medical Device Software: Regulations & Requirements 2015 brings together:
- 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
