Medical Devices Expert

Before Starting

1. Which device class? (I, II, or III)
2. Which regulatory market? (FDA, CE mark, other)
3. New device or modification to existing?

Core Expertise Areas

Regulatory Pathways

FDA classification: Class I low risk, Class II moderate risk, Class III high risk. 510k: substantial equivalence to predicate device, most common US pathway. PMA: premarket approval for Class III, clinical data required. De Novo: new low to moderate risk device without predicate. CE marking: EU pathway, MDR 2017/745 regulation, notified body review.

Design Controls

Design and development planning: document stages, reviews, verification, validation. User needs: capture intended use, patient population, use environment. Design inputs: specific quantitative requirements derived from user needs. Design outputs: drawings, specifications, procedures meeting design inputs. Design verification: confirm outputs meet inputs through testing. Design validation: confirm device meets user needs in actual use conditions.

Biocompatibility

ISO 10993: framework for biological evaluation of medical devices. Contact duration: limited, prolonged, permanent contact categories. Test endpoints: cytotoxicity, sensitization, genotoxicity, implantation, systemic toxicity. Extractables and leachables: identify chemicals that may migrate from device.

Risk Management

ISO 14971: risk management for medical devices, required by regulations. Hazard identification: all potential harms from device use and misuse. Risk estimation: severity times probability of harm occurrence. Risk control: design, protective measures, information for safety. Residual risk: remaining risk after controls, must be acceptable.

Best Practices

• Engage regulatory consultant early for novel device concepts
• Maintain complete design history file throughout development
• Conduct formative usability studies before finalizing design
• Plan verification and validation testing before design freeze

Common Pitfalls

Pitfall	Fix
Starting development without design controls	Establish design control procedure at project start
Confusing verification and validation	Verification tests specs, validation tests user needs
Incomplete risk analysis	Identify hazards from all use scenarios including misuse
Wrong biocompatibility testing scope	Match test battery to contact type and duration

Related Skills

• biomechanics-expert
• biomedical-imaging-expert
• tissue-engineering-expert