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 Expert  725163

Expert in Medical Device Regulatory Support, Medical Device Registration, etc.


Available for your Consulting and Expert Witness Needs

Florida (FL)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional with excellent communication and interpersonal skills and the unique ability to direct teams of people to achieve corporate goals.

He founded a consulting firm specializing in FDA Regulatory Support for Medical Device Firms. He prepares Regulatory submissions, developes training programs, conduct sinternal and supplier auditing and provide Quality System Support. In addition he offers ISO Certification Support including turn key systems for start-up firms. Provides support as a Lead Faculty Coordinator for numerous AAMI/FDA Training Programs including the Quality System Basic Course, Design Controls, Process Validation, Software Validation, Corrective and Preventive Action and ISO 13485. Also provides training on specialized topics such as Internal Auditing and Risk Management. In addition he provides Expert Witness Service to FDA during compliance cases against firms.

In addition, he started another firm to provide CE Mark, and European Authorized Representative Service for Medical Device Firms outside the EU. Currently the company has contracts with numerous firms, with one staff member in the UK.

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Current Good Manufacturing Practice

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disposable medical device

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electronic medical device

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European standard

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European statute

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Food and Drug Administration

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FDA medical device regulation

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Food and Drug Administration regulation

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Food and Drug Administration validation

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implantable device

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medical device

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medical device auditing

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medical device clinical research

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medical device design

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medical device evaluation

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medical device hazard analysis

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medical device inspection

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medical device irradiation sterilization

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medical device manufacturing quality control

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medical device package testing

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medical device packaging process

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medical device premarket approval

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medical device product development

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Medical Device Reporting regulation

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medical device sterilization

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medical device testing

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medical instrument

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medical pump

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Safe Medical Devices Act of 1990

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stent

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surgical instrument

The company has prepared many firms for ISO Certification and Notified Body review of CE Technical Files. More than 50 510K submission shave been made on behalf of firms and new companies have been registered with FDA and numerous international regulatory agencies.
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medical device registration

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510(k) document

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CE Marking

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ISO 13485


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Tampa, Florida;  Saint Petersburg, Florida;  Orlando, Florida;  Clearwater, Florida;  Cape Coral, Florida;  Lakeland, Florida;  Largo, Florida;  and Sarasota, Florida.

Often requested
with this expert:

Medical Device Regulatory Submissions
FDA Regulatory Consultant for Medical Devices, Cosmetics,...
Medical Devices
Professional QA & Regulatory Compliance for Medical...

Education:
Year   Degree   Subject   Institution   Honors
2006   Ph.D.   Business Administration   Kennedy-Western University  
1989   MBA   Management and Finance   Plymouth State University  
1970   BS   Electrical Engineering   University of New Hampshire   Honors

Work History:
Years   Employer   Department   Title   Responsibilities

2001 to

 

(Undisclosed)

 


 

President

 

This firm was started to provide CE Mark, and European Authorized Representative Service for Medical Device Firms outside the EU. Currently the company has contracts with numerous firms, with one staff member in the UK.

1999 to

 

(Undisclosed Consulting Company)

 


 

Founder

 

Consulting firm specializing in FDA Regulatory Support for Medical Device Firms. We prepare Regulatory submissions, develop training programs, conduct internal and supplier auditing and provide Quality System Support. In addition we offer ISO Certification Support including turn key systems for start-up firms. Provide support as a Lead Faculty Coordinator for numerous AAMI/FDA Training Programs including the Quality System Basic Course, Design Controls, Process Validation, Software Validation, Corrective and Preventive Action and ISO 13485. Also provide training on specialized topics such as Internal Auditing and Risk Management. In addition we provide Expert Witness Service to FDA during compliance cases against firms.

1987 to 1998

 

MERCURY MEDICAL

 

Quality and Regulatory Affairs/Technical Services

 

Vice President/Manager

 

Broad scope responsibilities encompassing manufacturing, regulatory affairs, quality assurance, engineering, international sales, human resources and technical services. Manage budgets exceeding $10MM and have extensive FDA involvement.

Developed complete Quality System to comply with new cGMP and ISO. Created team manufacturing programs to double production and decrease labor costs by 25%. Conducted acquisition due diligence and integration of purchased company, including the transfer of production from California to Florida in less than 30 days. Initiated and developed an International Sales Division achieving sales of $1.2 MM in 2 years. Introduced products to the European market accomplishing EN 46000 and CE marking registration in less than 6 months. Directed the technical team introducing a new anesthesia system, achieving regulatory clearance in only 11 months. Recruited, selected and trained a field engineering team while preparing and implementing a marketing plan increasing revenues from $500M to $4MM in 3 years.

1979 to 1986

 

HAEMONETICS CORPORATION

 

Facility & Operations/Equipment

 

Plant, Group & Division Manager

 

Managed two manufacturing divisions, materials, manufacturing and industrial engineering, operations and distribution. Responsible for implementing a full quality system at new Puerto Rico facility.

Planned and staffed a new manufacturing facility in Puerto Rico with over 100 employees reducing production costs by 20%. Established full regulatory compliance for sterile products. Introduced conveyorized assembly reducing labor time by 30% and expanding manufacturing facility and staff to support growth from $9MM to $40MM. Implemented team work cells for release of new blood processing systems shortening lead time by 3 months. Developed and implemented a Vertical Integration Plan for injection molding, extrusion and machining, reducing costs by 25% and improving quality.

1972 to 1979

 

AMERICAN OPTICAL CORPORATION

 

Optical Manufacturing

 

Electronics Project Engineer/Manager

 

Supervised an optical manufacturing facility of 80 people for medical and military instrumentation. As an electronics manufacturing engineer, provided support for electro-medical equipment.

Introduced high speed optical manufacturing systems, reducing labor costs by 50%. Designed work cells and PC board assembly system for the first electronic instruments built. Supported design engineers in two divisions with manufacturability and value engineering resulting in a 20% product cost savings. Developed new methods for thin film vacuum coating of instrumentation optics reducing cycle times by 30%.


Career Accomplishments:
Associations/Societies

Association For The Advancement Of Medical Instrumentation (AAMI):

Board of Directors, 1997-2000, Strategic Planning, 1998-2000, Finance Committee, 1996-2000, Program Committee, 1995-1998, AAMI Faculty for FDA and ISO Training Courses.

Professional Appointments

Keene State College Curriculum Development Committee


Consulting Services:
Selected Consulting Examples:
  • Prepared Regulatory submissions, developed training programs, conducted internal and supplier auditing and provided Quality System Support.
  • Offered ISO Certification Support including turn key systems for start-up firms.
  • Provided support as a Lead Faculty Coordinator for numerous AAMI/FDA Training Programs including the Quality System Basic Course, Design Controls, Process Validation, Software Validation, Corrective and Preventive Action and ISO 13485.
  • Provided training on specialized topics such as Internal Auditing and Risk Management.
Recent Client Requests:
  • Fda medical device mock audit for consulting on Mock audit to 21CFR820.
  • Expert in FDA regulatory auditors tampa, fl for consulting on Internal audit.
  • Expert for consulting on Need to draft and help implement GMP and QA programs...
  • Expert in 510k submission for a wound dressing gel to assist with FDA approval.
  • Expert in quality systems and auditing for FDA regulatory affairs.
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:
Expert Witness Experience Summary:
Provided Expert Witness Service to FDA during compliance cases against firms.
Recent Litigation Client Requests:
  • Expert medical device distribution standards for legal case involving counterfeit hernia mesh product
  • Medical device expert for consulting on medical device warnings.
  • FDA expert witnesses for consulting on FDA medical device and supply chain/distribution.
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.

Additional Skills and Services:
Training/Seminars

Numerous FDA, ISO and Auditor Training Programs including ISO 9001 Lead Auditor and ISO 13485


 

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