Medical Devices Quality Management System (QMS)
Focus:
• ISO 13485:2016, MDR 2017/745 and US FDA’s Quality System Regulation (QSR) Quality Management System (QMS) requirements explanation; relationship with ISO 14971:2019; QMS definition (i.e. processes scope); QMS evaluation (i.e. reviews and audits).
Audience:
• QA/RA/R&D/Software/ Manufacturing engineers involved in medical device products design, development, and manufacturing.
Duration:
• 1-day training course
Language:
• All materials are provided in English; The training can be given in English or Dutch
Medical Devices Risk Management
Focus:
• ISO 14971:2019 requirements explanation; links with ISO 13485:2016 and the MDR 2017/745; examples of methods and techniques for Risk evaluation; Risk Management impact on the medical device lifecycle; Risk Management planning; Risk Management reporting; Benefit-to-Risk Analysis; Risk-to-Benefit analysis; Risk Management File content
Audience:
• QA/RA/R&D/Software/ Manufacturing/Risk management engineers involved in medical device products design, development, and manufacturing.
Duration:
• 1-day training course
Language:
• All materials are provided in English; The training can be given in English or Dutch
Medical Device Design & Development Process
Focus:
Design & Development Process (stages); Risk Management; Design & Development Planning; Design Verification, Tools/Methods/Processes Validation (IEC/EN 60601-1, ed. 3.2; IEC/EN 60601-1-2, ed. 4.1; biocompatibility, sterility); Design & Development Documentation; Design Review; Design Transfer; Post-market surveillance.
Audience:
QA/RA/R&D/Software/ Manufacturing engineers involved in medical device products design, development, and manufacturing.
Duration:
1-day training course
Language:
All materials are provided in English; The training can be given in English or Dutch
Medical Devices Technical Documentation
Focus:
Design History File (DHF); Device Master Record (DMR); Device History File (DHR); Medical Device File (MDF); Summary Technical Documentation (STED)
Audience:
QA/RA/R&D/Software/ Manufacturing engineers involved in medical device products design, development, and manufacturing.
Duration:
0.5-day training course
Language:
All materials are provided in English; The training can be given in English or Dutch