• Regulatory Affairs
  • In vitro diagnostics

In vitro diagnostics

The IVDR (In Vitro Diagnostic Device Regulation) replaces the IVD Directive 98/79/EC, regulating all requirements for go-to-market and monitoring of in-vitro diagnostic devices. Concerning your products, we implement these new requirements for IVDs and their documentation.

In vitro diagnostics represent an interesting interface between science and medicine and form the basis for successful diagnostics and therapy.

We support you in converting your products to meet IVDR requirements. With our good network to notified bodies, ethics committees, associations and other decision makers, you have with us an expert partner at your side. We support you in:

  • Consultations on the classification of in vitro diagnostics
  • Preparation of performance reports
  • Communication with the appointed bodies

 

 

#invitrodioagnostics

Contact us. We’re happy to help!

Dr. Andrea Klüting
Vigilance & Regulatory Affairs
Business Development HWI group

Phone: +49 89 2000203-60
Email:

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Dr. med. Christian Schübel
Clinical Affairs/Medical Devices

Phone: +49 89 2000203-52
Email:

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0