Sue Hamann

WORK HISTORY

EDUCATION

ABOUT SUE HAMANN

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• ISO 13•••••03, EN ISO 13485:2012, ISO 13485:2016• MDSAP• Expert in Domestic and International Regulatory Affairs.• Authored chapters in several editions and versions of Fundamentals of 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 affairsHonored by the Regulatory Affairs Professional Society as a Fellow. Fellows are recognized for their contributions and leadership in advancing the regulatory profession and the RAPS organization.