Quality Management Systems & Medical Device Software Validation
This 3 day programme will give attendees a good grounding in the requirements for Medical Device Software validation and Quality Management Systems (QMS) Software validation. The course will cover the implementation of those requirements through Software Validation and Medical Device Software Life Cycles Processes. The course will cover the applicable requirements from both the Europe and the US. The course will include practical exercises covering the implementation of those requirements.
- Regulations and Guidelines for Software Validation
- The Software Validation Life Cycle
- Key Validation documents/activities
- Electronic Signatures and Records
- Risk Assessment: ISO14971 and IEC/TR 80002-1
- Contents of EN IEC 62304
- Design Control Requirements of 21 CFR Part 820
- Key Validation documentation/activities
- EN IEC 62366 Application of Usability Engineering to Medical Devices
Who should attend
Developers of Medical Device Software, and IT, Engineering and Quality personnel who need to gain a foundation in the principles and practices of QMS and Medical Device Software Development and Validation.
19 - 21 October 2021 (virtual classroom)