To a large extent, development of modern medical devices is driven by in-house production. You may very well uncover new possibilities in health care - but is your in-house production safe for medical personnel and patients? Let us run a system check. We can analyze the technical, operational, and organizational risks presented by your device combinations - and point out where there’s room for improvement. We can record the results in a final report, allowing you to submit a declaration of conformance with Appendix VIII of the EC Directive 93/42.
With TÜV Rheinland as your partner for risk management, you:
The system check is divided into four phases. The aim is to achieve flawless functionality and safety in your medical devices and systems. Our neutral experts assist you in meeting legal requirements and standards.
On-site risk analysis using an audit database. This will determine the current state of the system's operational parameters
Risk assessment and – where necessary - support in implementing improvements. An electrical system test can also be done as part of Phase 2
Final report - presented with an accompanying system file
Simplified declaration of conformance with Appendix VIII of the EC Directive 93/42