Martha Miller

Martha moved into medical device manufacturing after fifteen years experience as a registered nurse in both clinical and surgical areas. She then spent approximately twenty years in the medical device manufacturing industry, where her responsibilities included regulatory and quality compliance to FDA and international requirements. Further responsibilities included responsibility for clinical trials with submission of findings to FDA and international governments for approval to market new products. Working with a large medical device company allowed for a variety of products including implants for joint replacement, cochlear implants, measurement devices, soft goods and minimally invasive surgical instruments. Additional training and experience eventually landed Martha one of the top management positions in a division of a Bristol Myers Squibb Company handling both regulatory and quality responsibilities. This experience allowed her to see both sides of the bigger picture of business processes and to use this knowledge in assisting companies Specialties: Extensive experience with design, testing and manufacturing of various materials. Experience with validation of equipment and processes. Specific expertise in controlled environments. Experience with sterilization processes, including EtO, moist heat and gamma irradiation. Extensive experience with companies working to comply to ISO 9001:2008 (non-medical) ,ISO 13485:2003 as well as the FDA and Canadian regulations (medical).