An Introduction to Medical Device Software: Regulations & Requirements 2015

An Introduction to Medical Device Software: Regulations & Requirements 2015 is a conference dedicated to EU & FDA Guidance and Risk Management.

Key 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