Medical Device Safety, Standards, and Regulatory Compliance
Medical device safety, standards, and regulatory compliance tests how devices reach the market and stay there, and how standards and risk management shape design and postmarket action. The exam expects you to separate voluntary standards from legal marketing requirements.
Core rules and concepts
- FDA pathways: Class I/II/III risk-based; 510(k) for substantial equivalence to a predicate; PMA for high-risk novel devices; De Novo for novel low/moderate-risk types.
- Quality and risk: ISO 13485 quality management; ISO 14971 risk management across design, production, and use; IEC 62366 usability engineering.
- Standards: IEC 60601-1 general electrical safety, collateral standards, and particular standards for device types.
- EU: MDR 2017/745, CE marking, notified body involvement, UDI.
- Postmarket: recalls, adverse event reporting, corrections and removals, complaint handling. A 510(k) clearance establishes substantial equivalence, not superiority.
Worked example
A new wireless patient monitor is claimed as equivalent to a cleared monitor but adds a new intended use for home use. The addition changes the intended use; a 510(k) may not be sufficient, and the team should assess De Novo or PMA need, plus cybersecurity and usability evidence.
Traps
CE marking is not FDA clearance. Meeting IEC 60601-1 does not by itself authorize marketing. A safety notice is not always a recall; classify the action correctly.