Profile Details

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Hire Dr. Florence L.

United Kingdom

USD 120 /hr

Medical Device & IVD Regulatory Affairs and QMS Advisor | MDR, IVDR, UKCA, FDA (60 minutes consultation)

Profile Summary

Medical Device and In-Vitro Diagnostics Regulatory Affairs and Quality Assurance (QARA) professional with 6+ years’ experience supporting medical technologies from early research through to commercialisation readiness. I advise early-stage teams, academic spin-outs, and startups on regulatory pathways, risk management and proportionate Quality Management Systems across AI/ML SaMD (Software as Medical Device), IVDs, hardware and complex hardware-software medical devices. My focus is on helping teams make sound regulatory decisions early, avoid costly missteps, and prepare for future regulatory submissions, audits and investment.

Subject Matter Expertise

• ☆ Biotechnology & Bioengineering
• ☆ Biomedical Engineering
• ☆ Computer-Aided Engineering
• ☆ Mechanical Engineering
• ☆ Robotics Engineering
• ☆ Engineering Design
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Product Design
• ☆ Product Prototyping
• ☆ CAD & 3D Modeling
• ☆ Design for Manufacturing
• ☆ 2D Drawing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Presentation Design

Services

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Prototyping

Work Experience

Quality Assurance and Regulatory Affairs (QARA) Manager

Imperial College London

March 2024 - Present

Postdoctoral Researcher

Imperial College London

November 2019 - January 2024

Regulatory and Quality System Engineer

Axxin

October 2018 - November 2019

Technical Project Lead

Siemens Medical Instruments

November 2013 - October 2014

R&D Engineer

Siemens Medical Instruments

September 2011 - October 2013

Education

PhD

The University of Melbourne, Australia

October 2014 - July 2019

Masters (by Research)

National University of Singapore

August 2007 - March 2010

Certifications

• PhD

  The University of Melbourne

  July 2019 - Present

Publications

JOURNAL ARTICLE

Florence Leong, Chow Yin Lai, Siamak Farajzadeh Khosroshahi, Liang He, Simon de Lusignan, Thrishantha Nanayakkara, Mazdak Ghajari (2022). A Surrogate Model Based on a Finite Element Model of Abdomen for Real-Time Visualisation of Tissue Stress during Physical Examination Training . Bioengineering.

Leong, F., Garbin, N., Di Natali, C., Mohammadi, A., Thiruchelvam, D., Oetomo, D. and Valdastri, P., 2016. Magnetic surgical instruments for robotic abdominal surgery. IEEE reviews in biomedical engineering, 9, pp.66-78.

Leong, F., Huang, W.H. and Chui, C.K., 2013. Modeling and analysis of coagulated liver tissue and its interaction with a scalpel blade. Medical & biological engineering & computing, 51(6), pp.687-695.

Mohammadi, A., Samonas, D., Leong, F., Tan, Y., Valdastri, P. and Oetomo, D., 2017. Modelling and Control of Local Electromagnetic Actuation for Robotic-Assisted Surgical Devices. IEEE Transactions on Mechatronics.

CONFERENCE PAPER

Gu, H., Bain, M., Yen, C.J., Fang, S., Leong, F., Mohammadi, A., Valdastri, P. and Oetomo, D., Local Magnetic Actuation Based Laparoscopic Camera for Minimally Invasive Surgery.

Leong, F., Mohammadi, A., Tan, Y., Valdastri, P. and Oetomo, D., 2016. Experimentally Validated Modelling of Electromechanical Dynamics on Local Magnetic Actuation System for Abdominal Surgery. In Procs. Australasian Conference of Robotics and Automation.

Leong, F., Mohammadi, A., Tan, Y., Thiruchelvam, D., Valdastri, P. and Oetomo, D., 2017, June. Magnetic Interactions of Neighbouring Stator Sets in Multi DOF Local Electromagnetic Actuation for Robotic Abdominal Surgery. In IEEE/RSJ International Conference on Intelligent Robots and Systems. IEEE.

Leong, F., Huang, W.H. and Chui, C.K., 2008. Modelling and Simulation of Tissue and Device Interaction using Standard Viscoelastic Model. In IEEE International Conference of System, Man and Cybernetics. IEEE.