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Martha Miller
Background
Martha is a regulatory professional with extensive experience in domestic and international regulatory affairs. Her career in the Health Care arena spans over 30 years, and includes experience in the design, development, manufacturing and sale of medical devices.
Martha received her diploma in nursing and held several management positions before beginning her industrial career in the area of clinical research for medical devices.
Prior to joining SAI Global, Martha worked for almost 20 years in the regulatory area of both large and small corporations, including divisions of Smith & Nephew and Bristol-Myers Squibb. Her responsibilities covered the areas of new product approvals and compliance to domestic and international requirements. The variety of devices manufactured by these companies has given her a wide range of experience with both manufacturing processes and quality systems.
Martha has designed and incorporated programs for the implementation of quality systems for compliance to both the ISO requirements and the FDA Quality System Regulations (QSR).
Martha has lectured throughout the United States and abroad on the indication and use of various medical devices.
Specialties
Martha specializes in medical devices. She has in-depth experience in 510(k)/PMA submissions, IDE/clinical trials, GMP/ISO compliance, International Registrations, EC activities and regulatory requirements of the FDA, DOH, EPA and OSHA.
She has assisted numerous US companies integrate international regulatory requirements.
Credentials
Martha received her diploma from Methodist Hospital School of Nursing in Memphis, Tennessee, with associated classes at Memphis State University.
Martha is currently in the process of registering with the IRCA as a Lead Auditor.
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