Medical Device Experts

The medical device experts at Robson Forensic include a team  of highly qualified biomedical engineers that are qualified to analyze the design and manufacture of a device, as well as the installation and cause of potential adverse health reactions.

Design, Manufacture, and Installation of Medical Devices

Robson Forensic experts in biomedical engineering have developed and implemented a complete protocol for cases involving medical devices including retrieval, analysis, and storage of explanted devices. Our engineers investigate cases involving device failures.

Casework Includes:

1. Instruments, Implants, and Assistive Devices: 
   Examination of a broad spectrum of medical devices, including surgical tools, implanted devices, and mobility aids, to identify potential issues.
2. Pre-market and Post-market Mechanical Testing:
   Rigorous testing performed both before market release and during post-market surveillance to evaluate device durability and reliability.
3. Pre-market and Post-market Wear Testing: 
   Assessment of device wear patterns over time to understand component performance and material degradation.
4. Kinematic and Kinetic Analysis of Human Movement: 
   Detailed evaluation of how devices interact with human biomechanics, analyzing forces and motion to identify failure points.
5. Assessment of Foreseeable Use and Misuse: 
   Investigation of both intended device applications and possible improper uses to anticipate risks and failure modes.
6. Design Safety Assurance and Risk Evaluation: 
   Comprehensive review of device design to ensure compliance with safety standards and mitigate potential hazards.
7. Product Labeling and Warning Adequacy: 
   Critical analysis of device instructions, warnings, and labeling to confirm they adequately inform users and reduce misuse risks.
8. Device Performance Specifications and Regulatory Compliance: 
   Verification that devices meet all relevant technical standards and regulatory requirements.
9. FDA Submissions, Regulatory Support, and Recalls: 
   Support for regulatory documentation, including FDA submissions, and assistance managing product recalls when necessary.
10. Comprehensive Medical Device Evidence Collection and Testing: 
    Systematic collection of evidence and execution of specialized testing to support case investigations.

Medical Device Evidence & Testing

Robson Forensic offers a fully appointed medical device and biological laboratory to assist clients with managing the storage and inspection of medical products, and associated equipment. Our highly trained professionals can assist clients through the entire process, from the retrieval of evidence, through storage and inspection. Visit our Medical Device & Research Laboratory page for more information.

Discuss Your Case With an Expert

Call or submit an inquiry to tell us about your case. Once we determine which expert is best qualified to assist, we will put you in direct contact.