With a cross-disciplinary approach, deep bench of talent in virtually every discipline, and knowledge of and contacts with U.S. government agencies, we help clients operate, expand, and achieve their long-term business objectives helping you navigate the landscape wherever you do business. Our regulatory team was designed to deal with the FDA at the most senior levels, both engineering and scientific, in order to communicate effectively on your behalf.

The industry know-how we possess can help you implement strategies from initial concept development to market launch, or can assist you on any one component of the project, wherever and whenever you need assistance.

Our regulatory team currently consists of scientists, engineers, clinical project managers, former regulatory executives, and biostatisticians. The team is led by former CDRH Branch Chief Glenn Stiegman who has over 20 years of experience working in orthopedic, vascular, and other research regulation for the FDA. They are responsible for many of the most recent clearances and regulatory approvals in all areas neuro-musculoskeletal, including biologics, reconstruction/arthroplasty, spine, extremities, and sports medicine. Our regulatory team is fully integrated with the Clinical (CRO), Reimbursement, Quality and Program Development, and Compliance Divisions of MCRA, which creates the significant value added capability required in an ever changing environment.

SHA’s regulatory services include: