EN ISO 14971:2007 risk management for medical products is the actual legal standard.

Behind the risk management you can see the realisation, that market experience from the beginning is an important input which must be used in your risk analysis. So product risk is subject to continuos evaluation and if necessary to further measures.

The risk management process covers the whole life cycle of your medical product. It covers all divisions of your organisation and includes the customer. Risk management is an important new requirement of the new ISO 13485:2003

We implement the risk management process in your quality management system. We deliver a software tool esspecially tailored for your products.

Qware Risk manager (R)

Your Benefit:

• Reduction of annoying recurring labour
• Always up-to-date: You and your team can always see the whole risk analysis and the risk management graph online
• Significant reduction of your manual documentation
• Integrated project management for your measures
• Compliance with all regulatory requirements
  

It takes the form of several workshops we guide you through the whole risk management process by using one of your medical devices as an example.

• With learning by doing you learn in practice how risk management works
• You get an updated risk analysis of a product including all documents required
• Autonomously tailoring your process to suite your quality management process
• With the schooling you improve the qualifications of your staff
  

1. Analysis of the situation:
   Examination of the documents, on-site findings of the products
2. Basic workshop:
   Input: What is risk management, risk graph, structuring of the risk analysis
3. Workshop – potential hazards
   Brainstorming: Potential hazards and evaluation of the potential hazards
4. Measures – Workshop
   Brainstorming measures, evaluation of the measures-effect and risk acceptance
5. Compilation of the risk management file
6. Implementation of the risk management process in the quality management system

If you want to know more about this subject we would be pleased to see you in one of our lectures about risk management. Ask for our supporting documents. If this matter is of interest to you we will send you a presentation of a risk management file.