Safe products
Risk management
Risk… by definition, we are talking about negative events that occur with a certain probability. We don’t want the success of your product to become a ‘dice game’. What we don’t promise you: That we simply eliminate risks; it is partly out of our hands. When it comes to risk management, we help you to reduce the risks
- to know as far as possible: Uncovering distant cause-and-effect relationships is also important and provides you with a solid basis of information for your decisions.
- Reliably assess: A clear prioritization of the identified risks gives you transparency so that you can use your resources most effectively.
- Approach efficiently: Fast and focused reactions, or even better, proactivity instead of reactions, will bring you high-quality results.
Understanding your risks and taking early action will save you time and money during development and the product lifecycle. After all, risks that have been addressed in advance will not lead to a failure in the market. For product developments in medical technology, we work in accordance with DIN EN ISO 14971. In addition, we carry out FMEAs and other quality methods and, if necessary, in-house and train your employees to use these methods independently.
Project examples:
- High-voltage distributors in electromobility
- Risk assessment of the manufacturing process for spinal implants
- FMEA in infusion technology during development