Former FDA inspector with thirty-one years of experience.  Professional consultant specializing in mock FDA compliance audits for the Medical Device industry.

Titles Held: Senior Consultant; Regulatory Manager; Medical Device Specialist

• Quality System and Regulatory Affairs from an FDA Perspective; Provide training for FDA’s Quality System Regulations for the Medical Devices industry
• Provide expertise in how to handle an FDA inspection; understanding the Quality System Inspection Technique (QSIT) for an inspection by FDA; Comparing FDA’s QSR to ISO 13485 Standard Compliance
• Working knowledge of Medical Devices Classes l through III and all types of devices, mostly in electromechanical, plastics and latex products
• International experience conducting various inspections and audits of products and facilities in Malaysia, Mexico, Germany, Switzerland, Indonesia, England and reviewed clinical studies for medical devices in Thailand
• Experience working with Medical Device manufacturers of all sizes, with multiple product lines and multiple sites