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In-House Production of Medical Devices – System Check

In-House Production of Medical Devices – System Check

Risk Assessment for In-House Device Production and Combination

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.

Benefits at a Glance

With TÜV Rheinland as your partner for risk management, you:

  • Get an analysis confirming the functionality and safety of your devices and systems produced in-house
  • Minimize your risk of liability
  • Make a good name for yourself - by fulfilling your duty of care with regard to your patients
  • Guarantee your compliance with regulations on medical device operation and new treatment methods
  • Get the support of specialized medical technicians with many years of experience - and nationwide presence
  • Benefit from our status as a neutral, officially-approved inspection authority - providing utterly unbiased results your clients know they can trust
  • Get one-stop service
  • Receive an individual safety package filled with additional assessment services
  • Gain control over potential risks

Our Approach

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.

Phase 1:
On-site risk analysis using an audit database. This will determine the current state of the system's operational parameters

Phase 2:
Risk assessment and – where necessary - support in implementing improvements. An electrical system test can also be done as part of Phase 2

Phase 3:
Final report - presented with an accompanying system file

Phase 4:
Simplified declaration of conformance with Appendix VIII of the EC Directive 93/42

Legal Standards of Our Services

  • Law on medical devices (Medizinproduktegesetz, (MPG)
  • Medical device operators regulation (Medizinprodukte-Betreiberverordnung, MPBetreibV)
  • Regulation on medical devices
  • 93/42/EEC guideline for medical products (basic requirements)
  • Standards, such as the DIN EN ISO 14971 or DIN EN 62353 norms
  • Regulation on workplace safety
  • Hygiene/electrical/building regulations
  • Manufacturer information


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Contact us to request a non-binding offer

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