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FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing. He is considered one of the national experts in process validation and design control for medical device manufacturers. A biomedical engineer, Expert has experience in a number of medical device manufacturers including heart pacemakers and defibrillators and he also was a Field Engineer with the U.S. Food and Drug Administration. He works primarily with implantable or life-sustaining products. His experience with FDA regulations is particularly useful in helping with the speedy approval of medical devices. In addition, his experience has fostered contacts with the FDA leading to a positive relationship.

MEDICAL ELECTRODES. During his career, Expert has been directly involved in the development and clinical use of medical electrodes, particularily polymer electrodes for use with external defibrillators and pacemakers.

IMPLANTABLE DEVICES. Expert has played an integral part in the development of cardiac pacemaker products for both internal and external applications, of external automatic defibrillators, and of other implantable devices.

MEDICAL DEVICE MANUFACTURING; GOOD MANUFACTURING PRACTICE. Expert's knowledge of manufacturing requirements also helps in the development of manufacturable products. He has overseen several products through the development cycle to marketing. He is very familiar with good manufacturing practice systems for medical device manufacturing. He is presently using his expertise to assist a computer-controlled surgical device company in all of these areas. Other related specialties for Expert include pacemaker products and medical hybrid-circuit quality assurance.


Expert is a quality system consultant for medical device manufacturers.He implements process validation programs and conducts qualifications.He consults in product design and implements design control systems.

Over thirty years of broad experience and management accomplishments in the Medical Device area including training, medical device engineering and development, manufacturing including process validation, and quality assurance systems. Regular presenter for various national meetings on medical device quality and regulation, editor of the Biomedical Quality Auditor Handbook, certifying consultant for FDA related compliance actions for large and small medical device manufacturers.
Sole independent/non-regulatory contractor to FDA and International Organizations to develop the content and audit structure for the Medical Device Single Audit Program.
The experience specifically includes:
• Process Validation
Nationally Recognized Expert
Program Development and Implementation
• Medical Device Product Development and Design Control
Nationally Recognized Expert
• Risk Management
Nationally Recognized Expert
Training
Program Implementation including procedures and implementation in quality systems.
• CAPA and Complaints
Developed systems to integrate risk in the CAPA and Complaint system
• cGMP and ISO 13485 Quality System Development
Quality Systems for Emerging Companies
Design Control and Project Management
Complaint and CAPA (with integrated Risk Management)
Risk Management
• Auditing
(Quality Systems Lead Auditor, RAB Q05801, CQA, BQA)
Editor of the Biomedical Quality Auditor Handbook
• Training
Quality Systems
Process Validation
Risk Management
Complaints and CAPA
• Software Validation
Quality System Procedures
V&V Test Protocols
• FDA Expert
Expert support on compliance actions to FDA
MDSAP - Medical Device Single Audit Program Contractor to FDA in development

Regulatory Experience
• Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016
• Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
• Brazilian Good Manufacturing Practices (RDC ANVISA16/2013)
• Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
• Quality System Regulation (21 CFR Part 820)
• Canada Regulation SOR 98-282 as applicable (note Canada conforms with ISO 13485:2016 and MDSAP)

Key Accomplishments:
• Managed research, development and operations for the initial developers of the Automatic External Defibrillator (AED) technology.
• Managed Process Validation programs for numerous client companies including program development, procedure writing and implementation, training, master plan development, protocol development, and protocol execution.
• Implemented ISO 14971 based risk management programs at client companies.
• Developed Project Management and Design Control systems for client companies that meet ISO and FDA requirements.
• Acted as certifying consultant in several FDA consent decree situations with client companies, including successful removal of the consent decree situation.
• Regular speaker on cGMP issues including QSIT, Process Validation, Risk Management, CAPA/Complaints, cGMP implementation and Design Control at national meetings including meetings co-sponsored by the FDA.
• Internal training for companies including skill evaluation.
• Expert witness for U.S. Food and Drug Administration
• Developed medical device manufacturing and quality systems for start-up and established medical device manufacturers.