Since April 2022 Timothy Davison has joined the Qserve Group as Principal Consultant where he is part of the IVD team.
Timothy about working at Qserve
I am a passionate results-driven consultant and excited to join the great experienced IVD team of experts. Due my former position as subcontractor within Qserve I already know the professional team and I’m happy to fully deliver my contribution to customers.
Tim has more than 20 years of experience in the industry with extensive expertise in IVD and medical device product development and validation.
Prior to joining Qserve, Tim has held senior positions in medical device, pharmaceutical and in vitro diagnostic product development, and service delivery companies. Within the IVD industry Tim has worked on prognostic, predictive, risk stratification, and companion diagnostic assay development and delivery with a focus on complete end-to-end solutions.
Tim has a breadth of experience in the development and application of machine learning and artificial intelligence pipelines for in vitro biomarker development and delivery in oncology and immunology disease areas. He also has recent experience applying these skills in the development of digital biomarkers combining medical devices with gamified cognitive and behavioral tasks for dementia and depression.
Tim has a PhD in Medical Biophysics from the University of Toronto, and a bachelor’s degree in Applied Mathematics from the University of Waterloo.
The key expertise areas of Timothy:
- Advising on IVD biomarker development, analytical verification and validation study designs and analysis across multiple molecular platforms including PCR, microarray, and next generation sequencing technologies
- Application of the design control process (21 CFR 820 and ISO 13485) for IVD and medical devices
- Translation of intended use and user needs into acceptance criteria and analytical specifications for assay precision and cut-off determination
- Application of ISO 14971 risk management including hazards analysis, design and use FMEA, and risk mitigation
- Advising on the implementation of control procedures for assays delivered under ISO 15189
- Advising on design, development, verification and deployment of machine learning and artificial intelligence software pipelines and products with an emphasis on explainability, reproducibility, and forensic evaluations for the purpose of identification and reduction of bias through application of Good Machine Learning Practices (GMLP)
- Advising on Software including IEC 62304 Software Lifecycle using both Waterfall and Agile development methodologies for both IVDs and medical devices
- Advising on design controls, user needs, requirements, specifications, risk analysis and verification of in vitro diagnostic products, electromechanical medical devices with embedded software, software in a medical device (SiMD), software as a medical device (SaMD) and digital biomarker technologies
- Advising on interpretation and implementation of requirements for 21 CFR part 11 (Electronic Records; Electronic Signatures) and GMP Annex 11 (Computerised Systems)