Michael A. Daniel
Cynthia Harris
Mark Smutka
Ping-Yu Liu, Ph.D.

- Twenty eight years of regulatory, clinical, and quality experience
- Extensive experience formulating clinical and regulatory strategic plans and integrating into business plans.
- History of successful regulatory submissions including IDE, PMA, 510(k) and international submissions.
- Successfully obtained CE Marking for Class II and III medical devices.
- Responsibility for QSR, GLP and GCP compliance; ISO 13485 and MDD certification.
- Expertise in clinical trial design, study management, data analysis, and presentation of clinical results.
- Management of clinical trials in the United States, Europe, New Zealand, and Australia.

Experience with medical device companies on all relevant aspects of clinical and regulatory affairs, including regulatory strategy, regulatory compliance, regulatory submissions (510(k), IDE, PMA, Technical File, and Design Dossier), preclinical testing, clinical study design, clinical study management, data analysis, and report writing. Clients include medical device manufacturers producing cardiovascular, orthopedic, urological, renal, obesity, ENT, pulmonary, and other types of products.