Medical Device Software: Complying with the EU MDR, EU IVDR & 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 EU MDR, EU IVDR & 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
EU - European Union
MDR - Medical Device Regulation
IVDR - In-Vitro Diagnostic Regulation
FDA - Food and Drug Administration
