Biomedical Electrical Engineering Consultant Specializing in Surgical Devices, Quality and Regulatory Compliance

Technical Consultant #1498

25 years of experience related to medical device manufacture, quality and regulatory compliance.
Certified Quality Manager, American Association for Quality (ASQ ).
FDA 510K development and support and managing FDA 510K submissions.
FDA documentation and FDA warning letters.
Implementation of ISO 13485 resulting in a systematic quality management system for medical devices.
IEC60601-1 consulting for basic safety and essential performance of medical electrical devices.
Past medical devices projects include: Diagnostic systems; Ultrasound; MRI; CT; Defibrillator tester; ECG; Blood and Infusion warmer; IR Thermometer; Electronic Stethoscope; Dental implant and materials; Dicom; RF surgical; Ventilator graphic monitor; and, medical remote alarm.
Software Test verification and validaton (V&V) for all level of concerns.
Risk Analysis (ISO 14971) for medical devices.
Biocompatibility of materials used in medical devices.
Predicate device analysis.
Knowledgeable of CRF 21 Part 11 regarding electronic records for medical devices.

Undisclosed Company, Director of Regulatory Affairs, 2004 - Present

Compliance and regulatory affairs for start up medical device company.
FDA 510K development including numerous premarket discussions and documentation submissions with FDA.
Directed clinical study activities.
ISO 13485 QA system design and implementation.
Software verification and validation for FDA major level of concern.

Dentatus AB, Quality Manager and Regulatory Affairs Consultant, 2002 - 2004

Manufacture of dental Implants, dental materials and surgical devices.
Planned quality audit and corrective action program resulting in changes to factory organization structure.
Established cross-functional team to prepare SOPs for ISO 9001: 2000 requirements.
Established first, second and third party auditing procedures.
Acted on behalf of company during FDA audit to FDA QSR requirements; managed corrective action plan.
Regulatory projects: Obtained ISO13485 CMDCAS certification leading to Health Canada Certification; Prepared clinical test program and case study to enable long term indication for implants; and, worked with notified bodies to obtain CE marking.

BellSouth Products, Quality Manager and Consultant, 1994 - 1997

Lead development of quality mission statement, quality policy and to continually communicate this policy to staff and bottom line focused distributors.
Developed a Supplier Quality Assurance program.
Analyzed run charts of suppliers to determine statistical state of process.
Set up a domestic product design arm to create workmanship and design standards and reduce variation within the design of the products.
Conducted case study of customers leading to user manual revisions and design changes based on customer focus.
Headed domestic product verification and test group as responsibility was shifted to suppliers.

NATS Corp., Quality Assurance and Regulatory Compliance Consultant, 1990 - 2004

Project manager and leader for design and manufacturing projects for RF surgical and epilation units.
Lead QA registrations to ISO 9001: 2000 and ISO 13485, including preliminary and mock audits.
FDA Marketing clearances, 510K pre-market notification, GMP compliances. Health Canada, CE Marking for medical devices.

Underwriter's Laboratories, Compliance Safety Engineer and Manager, 1979 - 1990

Quality assurance program implementation.
Engineering Team Leader: Responsible for compliance team of engineers, assistant engineers, technicians, technical writers and support staff.

Credentials

Professional Affiliations