From Idea to IVD – Contract development & manufacturing of in-vitro diagnostics
March 26,

2018

From Idea to IVD – Contract development & manufacturing of in-vitro diagnostics

Biotype Innovation’s contract development service for molecular diagnostic innovations is expanding. Since our inauguration in April 2015, we offer integrated solutions that are customized to your requirements, including development, manufacture, and validation of genetic tests. Together with our longstanding partner, Biotype Diagnostic, we were now able to optimize our service portfolio even more.

Biotype’s premium contract development and manufacturing service covers all challenges right from the idea up to the large-scale production of a marketable in-vitro diagnostic product (IVD). Together, we select the best technology for your project and assemble a personalized team to guide you through the complete product realization process.

As two international biotechnology companies, we are committed to high-quality standards and will accommodate your individual product specifications. All product developments are performed in accordance with the FDA Design Control Guidance for medical devices (FDA Quality System Regulation 21 CFR Part 820) and will maintain the requirements of the new IVD regulation, which becomes effective in 2022.

By joining forces and through our continuous improvement process, we make sure to remain your premium service provider in future.

We look forward to working with you.

Find out more about our comprehensive service portfolio by clicking on this link: www.custom-solutions.biotype.de

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