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

Technical Consultant #1498


Expertise

  • 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.

Experience

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.

Honors & Publications

Credentials

  • ASQ Certified Quality Manager

Professional Affiliations

  • American Society of Quality
  • Regulatory Affairs Professional Society

Education

  • B.S., Electrical Engineering/Biomedical Engineering, Manhattan College, NY
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