Bruce H. Barkalow, Ph.D., PE, CCE
490 Quarterline SE
Newaygo, MI 49337-9201
Tel: (231) 652-2228
Fax: (231) 652-7912

Email: bhbi@riverview.net 
Web page: www.bhbi.com
 

Consultation for Law Firms and Attorneys
Expert Assistance and Consultation for Matters Related To
Medical Technology and Medical Devices

EXPERTISE:

Example Defense Case:
 See Closed Cases, Anesthetic Hypoxic Injury

Example Plaintiff Case:
 See Closed Cases, Anesthetic Overdose

Biomedical and Clinical Engineering Forensic Investigations:
  • Healthcare Organization Related:
    • In-house, shared service, vendor, or other third party medical device support.
    • Analysis of the hospital medical technology profile, identification of problem areas, defining required support resources, compliance with JCAHO medical device related standards, identification of medical technology risk exposure, and case-related technical advice as to the quality and quantity of  medical technology support.
    • Medical Device support personnel job descriptions and performance review.
    • JCAHO medical device related compliance.
    • Federal and State compliance with medical technology codes and standards.
    • Medical Device related User Training and Physician Credentialing criteria.
  • Medical Device Related:
    • Medical Device failure analysis
    • Medical Device incident simulations
    • Medical device labeling including: labels on the device; operator's manuals; and service manuals.
    • Representations of the medical device function and suitability for use.
    • User training.
    • Warranty and after warranty service support.
    • FDA 21 CFR related compliance.
CASE RELATED SUPPORT:
  • Confidential case file review for medical technology and medical device related issues.
  • Incident simulations and expert investigations as required.
  • Expert reports as required.
  • Deposition and Trial Testimony as required.

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