Medical Device Software: Complying with the MDR & FDA Regulations

Medical Device Software: Complying with the MDR & FDA Regulations is a course that covers topics such as:

• The MEDDEV on Stand Alone Software
• The Regulatory Framework
• The Practical Construction of a Technical File
• The Principles to Bring a Medical Device Software Product to the Market
• FDA Guidance on Medical Device Software Systems and Mobile Apps
• The US Code of Federal Regulations and its Implications for Software
• The IEC and EN ISO Standards and their Applicability; including Risk Management and Usability
• Key Information on Design Aspects of Medical Software
• Design Activities; including Architecture Design , Configuration Management and Verification and Validation
• The Fundamental Principles of Quality Management Design Control

Medical Device Software: Complying with the MDR & FDA Regulations brings together:

• Internal / External Auditors and/or Consultants
• Senior Management, Project Leaders
• Quality Systems and Quality Assurance Personnel
• Regulatory Affairs
• New Product Development, Marketing
• IT Managers
• Document Control / User Manual Writers
• Software Product and Process /Manufacturing Engineering Staff
• R&D Software Engineering Team Members and GUI Designers

Medical Device Software: Complying with the MDR & FDA Regulations will be held on 05-07 May 2021.