Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management 2014 is a course focused on the following areas:
- Introduction into Risk Management and Quality System Integration
- Usability and Risk Management
- Safety / Assurance case
- Software Risk Management (IEC62304 / FDA software reviewers` guidance)
- Risk Management to ISO 14971:2012
Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management 2014 brings together:
- Quality professionals
- Enior quality managers
- Compliance professionals
- Regulatory professionals
- Design engineers
- Project managers
- Process owners
- Software engineers
- Quality auditors
- Quality engineers
- Legal Professionals
- Medical affairs