INTEGRATE DATA FROM REGULATORY, RISK MANAGEMENT, USABILITY ENGINEERING & CLINICAL EVALUATION
Requirements engineering for medical devices is different: There are several medical device specific interface processes that are closely linked to product development. They have a particular impact on stakeholder & design input requirements as well as verification & validation.
It's no secret: One of the biggest challenges in product development are "silos" of information. They arise from processes that are not interlinked and specialist process teams that are not able to exchange information efficiently.
In order to achieve integrated processes and efficient workflows, it is important to understand how the relevant processes interact with each other. What information from one process is important input for another process? And which activities from interface processes provide results for the verification and validation of a medical device as part of the product development process?
This Tech-Talk is relevant for people working in the medical device development.
Agenda
- Which input from other processes is required for medical device development:
- Regulatory documents: Laws, standards, guidances
- Risk management: Risk control measures
- Usability engineering: Requirements for user interface design
- Clinical evaluation: Clinical performance requirements, requirements derived from similar devices (state of the art)
- How can information from other processes be integrated efficiently?
- In which way are verification & validation activities connected to interface processes?
- Demonstrate compliance with traceability reports across processes
- Change management: Visualize dependencies of information for assessment of change impact before implementation
