Dr. Bernd KrämerSenior Director IVD

Bernd has more than 20 years’ experience and expertise in IVD, medical devices, infectious disease diagnostics in the areas of marketing, product management, communication, laboratory automation, R&D and IT.

He is a co-creator and co-developer of a biotech startup company to a globally operating provider of system solutions for the medical laboratory diagnostics and market leader in infectious serology with a distinct focus on IVD medical devices and their strategic positioning, development and registration worldwide.

Bernd is highly trained in IVDR 2017/746 with a deep understanding of the regulation requirements as well as practical implementation tools and strategies and our expert for requirements and risk management for IVD medical devices - with a special focus on software-based solutions.

He provides extended and profound support in CE compliant product development of multidisciplinary IVD test systems and is also experienced in ISO 13485:2016 transition projects.

Expertise:

  • In vitro diagnostics
  • Infectious diseases
  • Molecular genetics
  • Injection systems (intravitreal)
  • Lab-on-a-chip test systems