Devices Incorporating Tissues or Cells of Animal or Human Origin, or Their Derivatives: Data Expectations Under EU MDR
Koen Janssen
24 Jun, 2025
With an engineering background and four years of experience in life sciences, Koen brings sharp analytical and critical thinking skills to both internal and client projects. He specializes in regulatory submission planning, Regulatory Information Management Systems (RIMS), and the implementation of new tools and processes into existing operations. His expertise spans project planning and management, reference and master data management, computerized system validation, and system implementationāensuring seamless compliance and operational efficiency.
At Celegence, he leads regulatory initiatives, ensuring high-quality data integrity, process optimization, and seamless collaboration with stakeholders. With a strong background in clinical research and vendor management, he plays a key role in driving compliance and operational efficiency in regulatory services.
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