Matthew Strege

Matthew Strege

IEC 60601 expert
Consultant

Matthew is part of the US Regulatory Affairs team providing strategic perspectives from a regulatory authority’s point of view having worked for leading Notified Bodies in both a safety testing capacity and regulatory technical specialist capacity. Areas of expertise include medical device and in-vitro diagnostic device safety test planning, standard interpretation and application, technical documentation preparation, and global regulatory strategy.

The key expertise areas of Matthew
  • Training for Electrical Safety Testing, Usability, Software Development & Maintenance Processes, Post Market Surveillance, Risk Analysis, and Clinical Evaluations.
  • Experience reviewing technical files and clinical evaluations.
  • Direct experience in notified body audits identifying regulatory issues associated with Design and Manufacturing of active devices.
  • Development and implementation of risk management files for medical devices.
  • Planning and implementation of Usability validation protocols for medical devices.
  • Auditing software development processes for conformity with IEC 62304
  • Certified internal auditor to ISO 13485:2016.
  • Former global technical competence center for medical testing
  • Former member of CTL ETF-3 expert task force for medical equipment (IEC 60601-1)

  • Conducted testing on the following types of medical devices:
    • Hearing Aids
    • Syringe and Infusion Pumps
    • Positron Emission Tomography (PET) System
    • MRI Superconducting Magnets- Computed Tomography (CT) Systems
    • Celution System (for the transfer of adipose tissue)
    • Sphygmomanometer- Anaesthetic Respiratory System
    • Left-Ventricular Assist Device (LVAD)
    • Dental Ultrasonic Cleaners
    • Fundus Cameras and Retinal Cameras
    • Proton Beam Therapy System
    • Robotic Surgical Systems
    Before Qserve

    Matthew has a BSc degree in Bioengineering from the University of Illinois at Chicago, and a MSc degree in Biomedical Engineering from Northwestern University.

    Matthew has over 15 years of experience testing medical devices and in-vitro diagnostic devices and over 4 years reviewing technical documentation for compliance with global regulation. His experience and knowledge spans an international level, having had global responsibilities in US, Europe, and Japan, testing and reviewing active devices for standard conformity and CE Marking certification for a variety of medical devices (class I, IIa, IIb and class III). 

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