Internationally experienced Medical Device Professional with a strong record of accomplishments in FDA regulatory affairs, quality assurance, and product design. Expert in Good Manufacturing and Laboratory Practices compliance for the pharmaceutical and medical device industry. Excellent written and verbal communications and supervisory skills. Works well with employees, customers, regulatory officials, and suppliers. Registered Professional Engineer since 1980. Certified Quality Auditor (RAB). Working knowledge of: FDA, cGMP, IEC, ISO, UL and CSA standards, FDA Class I, II, and III devices, 510K, IDE, PMA. Works well in both small and large company settings.
1990 to present- Principal Engineer and Owner, Kamm & Associates, Deerfield, IL. (Consulting Engineering firm specializing in FDA regulatory affairs services for the pharmaceutical and medical device industry. Services offered: FDA Regulatory Auditing, Consulting, Training, Quality Assurance, ISO 13485 and cGMP compliance, CE Marking guidance, FDA submissions: 510(k), PMA, IDE. Process, Product, Software Validations. FDA-483 and Warning Letter responses. Clients include Abbott, Amplifon (Italy) Baxter, Datex-Ohmeda (Sweden, Finland), Johnson & Johnson, Nidacon (Sweden), Siemens (Sweden, Germany, USA).
1983 to 1990- Manager of Engineering, Bio-Logic
Systems Corp., Mundelein, IL (Manufacturer of Electrodiagnostic Equipment)
Managed the Engineering, Quality Assurance, and Regulatory Affairs functions.
Designed the first medical instrument to fit inside and interface with the IBM PC, the Navigator®. Designed the Brain Atlas® multi channel digital EEG recording system.
1982 to 1983- Director of Research and Development,
Cambridge Medical Instruments Group- Picker International, Ossining, NY.
(Manufacturer of Cardiology related medical instruments)
Directed the activities of a group of 20 including Project Managers, Software Manager, Electronic and Mechanical Engineers, Technicians, and Drafters.
1973 to 1982- Chief Engineer, Telemed Division,
Becton Dickinson & Co., Hoffman Estates, IL
Managed and directed the activities of a group of 6 Electronics Engineers and Technicians engaged in the design of biomedical instrumentation, telecommunications equipment, computer interfaces and computer systems for automated electrocardiography.
B.S. Degree, Electrical Engineering., Washington University, St. Louis, Missouri.
Software Validation Training
Senior & Life Member, Institute of Electrical and
Member, National Society of Professional Engineers
Member, American Radio Relay League.