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Medical Device Regulation & Compliance Laboratory
Research with a practical perspective
Examines medical-device compliance from development and market access to post-market oversight. Research addresses classification, technical documentation, risk management, vigilance, traceability and coordination of regulatory compliance responsibilities. Case studies explore how regulatory requirements become workable organisational processes and records that support product safety and corporate accountability.
Research themes
- Technical documentation
- Conformity assessment
- Post-market surveillance
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