We know and understand all the stringent medical regulations inside out

We know and understand EU and US 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, making certification a difficult and time-consuming task for many companies. We have in-depth knowledge of the guidelines, including CE, MDD/MDR, IVDD/IVDR, LVD and FDA, and can act as your local representative.

Do you need help or advice with the certification or marking of IVD or medical devices? We are here for you. 

Advice on regulations

Bringing a medical device or IVD to the market can be difficult. There are many aspects to take into account and many legal requirements to comply with. Having trouble figuring 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.

Technical documentation

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

CE marking

Do you want 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 can ensure that your product is CE-marked quickly and cost-effectively.

Certification support

Do you want your product to be certified? We offer internal and external support for certification processes such as writing legal documentation and helping with risk management activities. In addition, we can speak to notified bodies and test facilities with you or on your behalf and act as your local representative if you’re marketing abroad

Always according to the regulations

We can also provide support after CE-marking or certification. We will keep you informed of relevant changes in standards and regulations, and perform gap analyses. If we find any gaps, then we’ll follow up to ensure that you can quickly become compliant with the laws and regulations again.

Taking healthcare to a higher level

Unitron creates high-end life science devices. From design to end product, and from certification to serial production. We collaborate. We co-innovate. We turn your ideas into reality.

We’ve been doing this for global players in the medical sector for more than 30 years. How can we help you?

Take a look at our areas of expertise.