Expert Consulting Solutions
Services
Regulatory
Medical Device Regulatory Submissions Preparation including
510(k)s, De Novos, PMAs, HDEs, IDEs, Q-submissions, Breakthrough Device & STeP Designations, and 513(g)s
Regulatory strategy
Resolution of regulatory Agency deficiencies
Regulatory Agency meetings and negotiations
Other Services
Letter-to-file consult and review
Regulatory submission training and education
Marketing Claims review
Post approval and 522 studies and reports
Registration & Listing
US Agent
Clinical
Medical Writing
Case report form & electronic data capture development
Informed consent development