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Krohn BioConsult
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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
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Medical Writing
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Clinical Evaluations
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Biological Evaluations
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Cyber security and Artificial Intelligence (AI)
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Laboratory Animal Science – experimental design
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Regulatory Requirements – CE-marking and 510(k)
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Usability Requirements
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21CFR820
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MDD 93/42/EC / MDR 2017
Our Expertise
Krohn BioConsult has delivered to following results:
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13 Clinical Evaluations
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5 Biological Evaluations
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28 Peer-Reviewed International Papers
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510(k) Writing
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Design of Usability Processes
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UDI implementation
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MDR implementation
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