Prosper K.
Ivdr Product Assessor @SGS
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WORK HISTORY
Ivdr Product Assessor @SGS
SGS Belgium NV - Notified Body 1639 Assess IVD technical documentation for compliance with EU IVDR). Review Performance Evaluation Plans and Reports, including analytical and clinical performance evidence. Conduct GSPR gap analyses and conformity assessment evaluations. Review risk management files per ISO 14971. Provide expert feedback to manufacturers to support conformity assessment decisions.
EDUCATION
University of the West of England
PhD, Biosensors & Medical Diagnostics
Cranfield University
MSc, Medical Diagnostics
University of Cape Coast
BSc, Biochemistry
ABOUT PROSPER K.
I am an IVDR Product Assessor and Diagnostics Scientist with 12+ years of experience spanning IVD R&D, assay development, POCT innovation, biosensor design, and regulatory compliance. My expertise bridges deep scientific development and hands-on regulatory evaluation, giving me a unique ability to assess the technical, analytical, and clinical performance evidence required for EU IVDR conformity.I currently serve as an IVDR Product Assessor (Notified Body 1639), evaluating technical documentation, performance evaluation evidence (Annex GSPR compliance, and risk management files under ISO 14971. I also contribute globally as a CLSI Expert Panellist in Point-of-Care Testing, supporting standards development and best practices.Previously, I led multidisciplinary R&D teams in the development and optimisation of electrochemical biosensors, immunoassays, and automated diagnostic systems—successfully delivering innovations into verification and validation stages.Core Expertise:• EU IVDR (Annex IX, XI, IVDR Technical Documentation & CE Marking• POCT technologies• Analytical & Clinical Performance Evaluation• ISO 13485 QMS compliance• ISO 14971 Risk Management• Immunoassays & electrochemical biosensors• Assay optimisation & analytical robustness• Cross-functional leadership• Regulatory submissions & Notified Body processesI am passionate about supporting safe, high-quality diagnostic technologies and guiding manufacturers toward successful IVDR compliance.
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