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 Expert  721929

Expert in Product Approval and GMP Compliance to Medical Device Regulations


Available for your Consulting and Expert Witness Needs

Virginia (VA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
As compliance officer with the CDRH's Office of Compliance, expert was responsible for evaluating results of foreign and domestic inspections conducted by the agency based on current Good Manufacturing Practice Regulations. His experience with the FDA has given him a broad regulatory background with expertise in product approval and GMP compliance to medical device regulations.

Expertise in the preparation of applications, device approval process and compliance to FDA's quality system regulations.

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Current Good Manufacturing Practice

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Good Manufacturing Practice

Expert moved from scientific reviewer of medical device applications to Assistant Director of Standards Enforcement with responsibility for evaluating the conformance of devices to voluntary standards and to product specifications. As scientific reviewer of device applications for 10 years, he has had experience with the review and approval of premarket notifications (510(k)s), premarket approval applications (PMAs) and investigational device exemptions (IDEs) of surgical devices, orthopedic implants and a variety of cross-specialty devices. He has experiences with surgical devices and implants in the Division of Surgical, Rehabilitative and Orthopedic Devices. He has assisted manufacturers in the design of laboratory and clinical studies for submissions. He has also prepared and presented summaries of safety and effectiveness for FDA at advisory panel meetings.
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FDA medical device regulation

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Food and Drug Administration regulation

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medical device registration


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;  Frederick, Maryland;  Gaithersburg, Maryland;  Bowie, Maryland;  Richmond, Virginia;  Alexandria, Virginia;  Wilmington, Delaware;  and Lancaster, Pennsylvania.

Often requested
with this expert:

FDA Regulatory Consultant for Medical Devices, Cosmetics,...
Medical Device Total Quality
Medical Device Regulatory Support, Medical Device...
Medical Device Regulatory Submissions

Education:
Year   Degree   Subject   Institution  
1980   M.S.   Management Science   Frostburg State University, Frostburg, MD  
1971   M.S.   Bioengineering   Polytechnic Institute of New York, Brooklyn, NY  
1965   B.S.   Aerospace Engineering   Virginia Polytechnic Institute, Blacksburg, VA  

Work History:
Years   Employer   Department   Title   Responsibilities

1994 to

 

Expert's Firm

 


 

Senior Consultant

 

Expert is involved in a full range of consultant activities. His specializes in FDA device regulatory activities.

1993 to 1994

 

Food and Drug Adminstration (FDA)

 

OBGyn and Gastro-urology Branch, Office of Compliance, CDRH

 

Compliance Officer

 

He was responsible for the review of the manufacturing section of PMA's, inspection reports of manufacturers' compliance to good manufacturing practice regulations, classifying recalls and providing guidance to FDA field staff on preproduction design and validation methods.

1989 to 1993

 

CDRH, Office of Compliance & Surveillance

 

Division of Standards Enforcement

 

Assistant Director

 

Expert was responsible for managing the program to assess the conformance of medical devices to pre-market approval applications and notifications, both nationally and internationally.

1988 to 1989

 

FDA and Pan American Health Organization

 


 

FDA Midlevel Management Associate

 

Expert was on special assignments to the Pan American Health Organization in Washington, D.C., and the FDA district offices and test labs.

1981 to 1988

 

Food and Drug Administration

 

Office of Device Evaluation, CDRH

 

Senior Biomedical Engineer

 

He was the Senior Scientific reviewer of devices before they are introduced into the market.

1976 to 1981

 

Department of Defense

 

Defense Medical Standards Board

 

Chief of Technical Services

 

He was responsible for the review and approval of military specifications and standards used in the purchase of medical equipment for DOD hospitals and supply system.

1973 to 1976

 

U.S. Army

 

Army Medical Bioengineering R&D Laboratory

 

Project Engineer

 

Expert designed, developed, and tested rehabilitative, medical and hospital equipment for Army field hospitals. He directed the work of draftsmen and machine shop technicians.

1969 to 1970

 

Dynamics Corp

 

Reeves Instrument Division

 

Engineer

 

He developed digital/analog computer models for aircraft engine components. He also developed and tested the computer software and electromechanical components of flight performance and radar systems.



Career Accomplishments:
Associations/Societies

Expert has been a Certified Member of the Regulatory Affairs Professional Society since 1992 and a member of the Society of Professional Engineers since 1975. He is also a Member of the Volunteers in Technical Assistance (World Help Organization); the American Society for Testing and Materials, Committee of Urological Devices; and the Association for the Advancement of Medical Instrumentation.

Licenses/Certifications

He is a registered Professional Engineer in Maryland.

Medical/Professional Internships

From 1972-1972, he received a Presidential Internship to the Naval Aerospace Medical Research Laboratory, Pensacola, FL. As a Bioengineering Intern, he used his temporary one-year appointment to provide research and engineering support to the Cardiovascular Research unit, which evaluated the cardiovascular physiology of naval Aviators.


Publications:
Publications and Patents Summary

He is the author of over 10 publications.

Selected Publications and Publishers  
 - JDiNov, EMarch, Ctylka, Journal of Clinical Engineering  
 - Biomedical Instruments & Technology  
 - Medical Device and Diagnostic Industry  
 - Pan American Health Organization  
 - Food and Drug Administration  

Government Experience:
Agency   Role   Description
Food and Drug Adminstration   Various   Expert spent 15 years with the FDA.

Consulting Services:
Recent Client Requests:
  • Fda skin care packaging expert for consulting on fda regulations for skin care products packaging.
  • Expert for consulting on Need to draft and help implement GMP and QA programs...
  • Expert in quality systems and auditing for FDA regulatory affairs.
  • FDA expert for consulting on 510(k) pre-market clearance of spinal column prosthesis.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Medical device expert needed for consulting regarding a shoulder pain pump.
  • Expert for consulting on FDA medical device regulation.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

 

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