Medical Device Software An Incremental Approach to Risk and Quality Management 2018

Topics

• 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

Who should Attend

• Regulatory specialists
• Project managers
• Documentation specialists
• Quality assurance specialists
• Software team leaders and lead developers
• Test managers