Electromechanical design and safety compliance
Since 2022, Kevin has joined Qserve Group US Inc. as an electromechanical design and safety compliance consultant. He has been working in various technical roles in the medical device industry for over 15 years.
Kevin has developed a diverse, end to end experience including product and process development, safety and EMC certification, transfer to production, manufacturing and quality. He has held various roles as individual contributor, project manager and functional manager and has been responsible for aspects of design, certification or manufacturing of over 10 different medical devices, including sterile single use products and capital equipment systems and consoles.
The key expertise areas of Kevin:
Medical Device Development:
- ISO 13485 Design and Development: Planning, User Needs, Product Requirements, Specifications, Design Reviews, Hardware Verification & Validation Plans, Protocols and Reports, Transfer to Production, Design Change, Design History Files.
- ISO 14971 Risk Analysis: Create and contribute to Use, Design and Process FMEA including recommending risk mitigations.
- IEC/EN 60601-1 General Safety of Medical Devices: Planning, Execution and Remediation.
- IEC/EN 60601-1-2 Electromagnetic Compatibility of Medical Devices: Planning, Execution and Remediation.
- Particular Standards: IEC/EN 60601-2-24 (Infusion Pumps and Controllers), IEC/EN 60601-2-34 (Invasive Blood Pressure Monitoring), IEC/EN 60601-2-37(Ultrasound Medical Diagnostics).
Medical Device Quality and Manufacturing:
- ISO 13485 Production Provisions, Process Validation, Equipment Specification, Installation and Operational Qualification, Traceability, Non-Conformance Reports (NCR), Corrective and Preventative Action (CAPA), Continual Improvement Process (CIP).
Functional and Project Management:
- Hardware Design and Development Planning, Schedules, Phase Reviews, Engineering Functional Management, Team Leadership, Mentoring and Coaching.