DANIEL KAMM, P.E., C.Q.A.
Voice +1-239-234-1735
Fax +1-206-260-4162
Email fda.help.now@gmail.com
www.fda-consultant.com

QUALIFICATIONS SUMMARY

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.

KEY COMPETENCIES

• IDE, 510(k), and PMA Submissions (USA and Canada).   Over 200 510(k) clearances have been obtained.
• Process Validation for pharmaceutical, in vitro diagnostic, and medical device manufacturing
• Software Validation emphasizing FDA expectations
• cGXP Auditing, Consulting and Training (Drug and Device GMP, GLP, etc.)
• FDA-483 and Warning Letter Strategies
• Risk Analysis 

PROFESSIONAL SUMMARY

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). 

Regulatory Projects:

• Performed software risk analysis for software in diagnostic imaging submissions.
• Received PMA approval for a tissue adhesive.
• Received the first 510(k) ever for a digital breath alcohol meter.
• Assisted Abbott Laboratories in numerous process validation, software validation, and risk analysis projects for in-vitro diagnostic medical devices.
• Filed numerous (>200) successful 510(k) submissions for complex and computer controlled medical devices for companies around the world. Examples: Clinical Admittance Meter, Electrodiagnostic Systems,  EEG Software, EEG to MRI Fusion Software, Sperm Separation Medium, Apnea Monitoring System, Computerized Dental Probe, Microprocessor Controlled Panoramic Dental X-Ray System.  Received the first ever 510(k) clearance for a digital breath alcohol detector.
• Quality Assurance services for a pharmaceutical supplier to Merck.
• Good Manufacturing Practices auditing of a Novex-Pharma, a Canadian pharmaceutical firm. Good Manufacturing Practices auditing of suppliers to Takeda Pharmaceuticals.
• Assisted several companies (domestic and foreign) with successful responses to warning letters.
• Audited and consulted for one of the world's largest medical device manufacturers' European locations (Sweden and Germany). Helped the company become GMP compliant and get out from under a consent decree. Taught process validation, the new GMP's, design controls, and how to use the new FDA 510(k) guidelines.
• Served as GMP consultant for both companies which manufactured in-home AIDS test kits.
• Served as GMP consultant to a major X-ray imaging company after they received a warning letter. Instrumental in the removal of import detentions. Met with FDA officials in Washington to explain responses. Directed the compliance efforts to successful completion.

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.

EDUCATION

B.S. Degree, Electrical Engineering., Washington University, St. Louis, Missouri.

ISO Lead Auditor Training

Software Validation Training

PROFESSIONAL AFFILIATIONS

Senior & Life Member, Institute of Electrical and Electronics Engineers.
Member, National Society of Professional Engineers

Member, American Radio Relay League.

PAPER:  “An Introduction to Risk/Hazard Analysis for Medical Devices”