Medical Device Software An Incremental Approach to Risk and Quality Management 2018 is a conference that covers topics such as:
- All medical device standards intersect on the topic of risk management
- Software has introduced (or been blamed for) some serious safety hazards
- Risk information is available from multipl sources - use them!
- Risk analysis starts with the intended use statement
- Changes are often the biggest sources of risk
- Note that safety is an emergent property
- Applying engineering risk methods to software requires us to translate some concepts
- Don`t ignore the human factors side; understanding your users is crucial to safety
- Risks often arise when we add new features - so incremental risk management is the most effective
- Though standards draw a roadmap for risk management, WE must figure out the route
- Never conduct risk analysis by using a checklist from 14971
- Forget the notion that "software can`t hurt anyone"
- Exploding technology brings numerous chances for risk to multiply
Medical Device Software An Incremental Approach to Risk and Quality Management 2018 brings together:
- Regulatory specialists
- Project managers
- Documentation specialists
- Quality assurance specialists
- Software team leaders and lead developers
- Test managers
