In Vitro Diagnostics

CEplus GmbH is an international affiliate of Dr. Regenold, specializing in regulatory strategy and implementation for medical devices and in vitro diagnostics.

In the field of In Vitro Diagnostics (IVDs), product variety ranges from conventional reagents and kits to instruments and software. Our interdisciplinary team offers competent support throughout the development and certification of your product, from conventional ELSIA tests, stand-alone software, and diagnostic services, to high-risk List A products, and point-of-care test systems.

Our aim is to keep up with the latest technological and regulatory trends to provide you with customized and pragmatic solutions to:

• Certifiable product components
• Requirements engineering
• Designing analytical verifications and clinical performance evaluations
• Implementing CTS requirements
• Risk management and usability engineering

Our experience includes:

• List A & B products (e.g. HIV, hepatitis, CMV)
• Molecular diagnostics
• Software-based tumour stratification
• Point-of-care systems for infectious diseases
• Companion diagnostics (CDx)
• Personalized medicine approaches
• Prenatal diagnostics
• NextGen sequencing
• Blood-glucose meters
• Pregnancy/ovulation tests

For more information, visit us at: www.ceplus.eu

Have a question concerning IVDs? Contact us.