I've been involved with the Boston RAPS chapter for about 10 years, first as vice-chair for 3 years and chair for the last 7+ years.
Experienced Medical Device/IVD Consultant. Sue Hamann has over 30 years in industry and is happy to advise companies on Quality System development and on a range of regulatory issues including matters relating to regulatory strategy, regulatory planning, regulatory submissions, as well as a variety of other US FDA and international matters. Experienced in 510(k)s, Pre-Submissions (Pre-IDE), HDEs, Health Canada, European Technical Files and Dossiers, and a host of other countries.
• Competent advisor to Medical Device/IVD clients in support of their goal to comply in all aspects of domestic and international quality and regulatory issues with experience in FDA quality system remediation.
• Strong Quality Leader with experience in implementing and maintaining GMP and ISO compliant quality systems
• Expert in Domestic and International Regulatory Affairs.
• Subject matter expert on Design Controls and Risk Management
• Available for short-term and long-term consultations in the areas of medical device quality assurance and regulatory affairs