Dr. Bernd KrämerHead Business Unit 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
  • Lab-on-a-chip test systems
  • Combination Products
  • Design Control
  • Risk Management
  • Regulatory Affairs