Medical devices
Education
Fulfilling the requirements of CE marking is inconceivable without acquiring the appropriate knowledge. We provide training in all relevant areas related to CE marking of medical devices in the form that best suits your needs: open and outsourced or custom- ized training.
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Standard, legislation, guidance |
Description |
| ISO 13485 | Standard introductory training |
| ISO 9001, 14001 | Standard introductory training |
| ISO 13485 | Internal Auditor Training |
| ISO 9001, 14001 | Internal Auditor Training |
| MDR II., III. | Technical documentation |
| MDR 15. | Person Responsible for Regulatory Compliance (PRRC) |
| MDR XIV. | Clinical Evaluation |
| MDR III. | Post-market surveillance system (PMS) |
| MDR XIV. B. | Post-market clinical follow-up (PMCF) |
| MDR/IVDR | Cybersecurity |
| ISO 14971 | Risk management |
| EN 62366-1 | Usability Engineering |
| EN 60601-1 | Safety test of medical electrical equipment |
| EN 61010-1 | Electrical equipment for measurement, control, and laboratory use |
| EN 61010-2-101 | In vitro diagnostics (IVD) medical equipment |
| 2006/42/EK | CE marking of machines |
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2006/42/EC EN ISO 10218-X ISO/TS 15066 |
ICE marking of industrial robot and collaborative robot systems |
| EN ISO 12100 | Risk evaluation of industrial machines |
| (relevant standards) | Safety and technical requirements of machines |
| MDR | We offer 2 hours of preparatory training (including 15 minutes of consultation) |