Devices & systems
Regulatory Affairs & Quality
5 self-contained study topics — notes, diagrams, formulas, and worked examples for exams and GATE.
Topics
- ISO 13485 and QMSISO 13485 provides a quality-management framework tailored to medical-device lifecycle control. This topic ensures engineers understand how technical work is governed through documentation, traceability, and corrective systems.
- Medical Device Risk ManagementRisk management in medical devices identifies hazards, estimates risk, and applies controls throughout product lifecycle. The objective is not zero risk, but acceptable residual risk with demonstrated clinical benefit.
- Validation and VerificationVerification and validation together establish technical correctness and intended-use fitness of medical devices. This chapter emphasizes planning evidence before testing, not after failures occur.
- Clinical Evaluation BasicsClinical evaluation establishes whether a medical device achieves safety and performance claims in humans. It integrates literature, existing clinical data, and post-market evidence into a defensible scientific assessment.
- Regulatory Pathways India and GlobalRegulatory pathways differ by jurisdiction, so market access strategy must be planned early in device development. This topic compares India CDSCO, US FDA, and EU MDR routes with risk-based submission requirements.