in Germany -
around the world
New technology is very fascinating, but it can also be viewed with skepticism in some cases. We understand this. Especially because it involves something of the very highest value - health. This is an area where no risks are acceptable and where all of those involved must be absolutely confident that they are doing the right thing.
The repeatedly assured and meticulously and continuously controlled quality is the minimum requirement which we wish to fulfill with our quality standards. For you, it is the precondition to enable you to use our implants without any concerns and with the certainty that you are doing the right thing.
We give you this assurance:
- CE-label tested and certified by TÜV.
- Approved throughout Europe, Singapore and another 20 countries as a medical product of the very highest safety and regulatory class (class III and/or class D).
- Certified pursuant to DIN EN ISO 13485 and according to medical product directive 93/42 EEC.
- The most stringent testing and documentation requirements for quality assurance on the basis of internal laboratory tests and external independent testing institutes.
- Safety and traceability of every implant from the product to the patient is guaranteed.
- Already successfully tried and tested thousands of times in hospitals.