Expert Details
Medical Device Regulatory Support, Medical Device Registration, etc.
ID: 725163
Florida, USA
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.
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.
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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2006 | Degree: Ph.D. | Subject: Business Administration | Institution: Kennedy-Western University |
| Year: 1989 | Degree: MBA | Subject: Management and Finance | Institution: Plymouth State University |
| Year: 1970 | Degree: BS | Subject: Electrical Engineering | Institution: University of New Hampshire |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2001 to Present | Employer: Undisclosed | Title: President | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1999 to Present | Employer: Undisclosed | Title: Founder | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1987 to 1998 | Employer: MERCURY MEDICAL | Title: Vice President/Manager | Department: Quality and Regulatory Affairs/Technical Services |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1979 to 1986 | Employer: HAEMONETICS CORPORATION | Title: Plant, Group & Division Manager | Department: Facility & Operations/Equipment |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1972 to 1979 | Employer: AMERICAN OPTICAL CORPORATION | Title: Electronics Project Engineer/Manager | Department: Optical Manufacturing |
Responsibilities: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%. |
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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 |
Additional Experience
| Expert Witness Experience |
|---|
| Provided Expert Witness Service to FDA during compliance cases against firms. This involves reviewing all documents FDA has prepared against a firm for potential litigation and rendering a written report on the case. Meet with FDA legal staff to review report and prepare for the case. In addition have done expert depositions in cases for distributor vs. OEM and in hospital injury case involving medical equipment. |
| Training / Seminars |
|---|
| Numerous FDA, ISO and Auditor Training Programs including ISO 9001 Lead Auditor and ISO 13485 |
Fields of Expertise
Current Good Manufacturing Practice, disposable medical device, electronic medical device, European standard, European statute, Food and Drug Administration, FDA medical device regulation, Food and Drug Administration regulation, Food and Drug Administration validation, implantable device, medical device, medical device auditing, medical device clinical research, medical device design, medical device evaluation, medical device hazard analysis, medical device inspection, medical device irradiation sterilization, medical device manufacturing quality control, medical device package testing, medical device packaging process, medical device premarket approval, medical device product development, Medical Device Reporting regulation, medical device sterilization, medical device testing, medical instrument, medical pump, Safe Medical Devices Act of 1990, stent, surgical instrument, medical device registration, 510(k) document, CE Marking, ISO 13485, drug-eluting stent, sharps, neurosurgical device, consumer food product, anesthesia equipment, active pharmaceutical ingredient, centrifugal blood pump, polymer implantable device, EN 29000 quality standard, blood flow meter, clinical measurement, biocompatibility testing, medical device coating material, medical instrument sterilization, medical device corrosion, nerve stimulator, transcutaneous electrical nerve stimulator, medical pneumatic compression device, medical device soldering, medical oxygen concentrator, medical device reporting, disposable infusion pump, inhaler, ureteral stent, durable medical equipment, biomedical application, medical filter, plastic medical device, medical device packaging material, oxygenator, medical device safety, wheelchair, medical device endotoxin detection, electroencephalograph, electrocautery instrument, dilator, medical device sterility, Food and Drug Administration cosmetic regulation, disinfectant Food and Drug Administration regulation, therapeutic device, electrosurgical instrumentation, ureteroscopic device, Australian standard, biomedical instrumentation, electron-beam sterilization, clinical protocol, orthopedic implant, surgical implant device, medical device endurance testing, medical device product improvement, electronic medical device design, medical device reliability testing, medical device process validation, medical device mechanical stress analysis, medical device manufacturing, fault tree analysis, mechanical respirator, autoclave, orthosis, biomedical device, device code, drug regulation, biomedical instrument, prosthesis, infusion pump, failure modes and effects analysis, endoscope, biomedical diagnostic instrumentation, defibrillator, biomedical sensor, biomedical chemical sensor, bioinstrumentation