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Krohn BioConsult

Krohn BioConsult offers more than 20 years of scientific experiences within in vivo research and quality/regulatory aspects of medical devices

Services

Krohn BioConsult offers the following services:

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  • Project Management

  • Medical Writing

  • Clinical Evaluations

  • Biological Evaluations

  • Cyber security and Artificial Intelligence (AI)

  • Laboratory Animal Science – experimental design

  • Regulatory Requirements – CE-marking and 510(k)

  • Usability Requirements

  • 21CFR820

  • MDD 93/42/EC / MDR 2017

Our Expertise

Krohn BioConsult has delivered to following results:

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  • 13 Clinical Evaluations

  • 5 Biological Evaluations

  • 28 Peer-Reviewed International Papers

  • 510(k) Writing

  • Design of Usability Processes

  • UDI implementation

  • MDR implementation

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