BIOTYPE is IVDR-certified!

After an intensive, almost two-year process, BIOTYPE GmbH has received the certificate for our quality management system and for our first IVDR products according to (EU) 2017/746!

From the submission of the application, through the intensive review of our technical documentation for the first product sample, to the final decision, it has been a demanding and challenging journey. But our team overcame it all with dedication, expertise and perseverance.

This success is an important step in our further development and confirms our commitment to the highest standards of quality and safety in precision diagnostics.

Today we are celebrating this milestone - and at the same time we are looking to the future full of vigour.

We would like to thank everyone who has contributed to this success!

Follow us for more updates and insights into our IVDR journey and future innovations!