Regulation and certification

We know and understand all the stringent medical regulations inside out.

As experts in the field of technical documentation, life-cycle management and product certification, we can guarantee that your product meets all the requirements.

Medical laws and regulations are complex. Certification is a difficult and time-consuming task for many companies. We know the guidelines inside out and are experts in the field of technical documentation, lifecycle management and certification guidelines such as CE, MDD/MDR, IVDD/IVDR, LVD and FDA. Do you need help or advice with the certification or marking of medical devices? We are ready to help.

Need advice? Please get in contact with us

CE marking
Do you want a CE marking for your product? An MDR or IVDR screening and impact analysis is the first and most important step we can take for you. This report provides essential insights and the best project approach for assessing conformity. It is an essential part of your technical documentation. Together, we ensure that your product is CE-marked within a short period of time and at a minimal cost.

Technical documentation
Every manufacturer of medical devices is obliged to compile and maintain technical documentation. We can support you in building your technical file. We also help with other obligations associated with the launch of a life science product. Or we can assess your existing documentation for certification and design transfer.

Advice on regulations
Bringing a medical device to the market can be difficult. There are many aspects to take into account and many legal requirements to comply with. Can’t quite figure it all out, or do you just need a second opinion? We’d be happy to look at it with you and make sure that you can move on.

Certification support
Do you want a product certified? We offer internal and external support within certification processes. Such as writing legal documentation and help with risk management activities. In addition, we can speak to notified bodies and test facilities together or on your behalf.

Always according to the rules
We can also provide support after marking or certification. We will keep you informed of relevant changes in standards and regulations, and perform gap analyses. And if any gaps are revealed? Then we’ll follow it up, so that you are again complying fully with the laws and regulations.

Taking healthcare to a higher level

We create high-end life science devices. From design to end product, and from certification to serial production. We have been doing this for global players in the medical sector for more than 30 years. Together, we’re taking healthcare to the next level.

Take a look at our areas of expertise