Our medical device consulting team is the most talented experts with experiences as being FDA ex-reviewers at CDRH and/or the MedTech industry. Accomplishments in consulting services toward approvals for general medical devices and IVDs such as:
- Gap Analysis
- Classification of Device and Understand Applicable Risk-related Controls
- Regulatory Strategy and Pathway Assessment
- Pre-Submissions
- 510(k) (Premarket Notification)
- PMA (Premarket Approval)
- De Novo Classification Request
- HDE (Humanitarian Device Exemption)
- IDE (Investigational Device Exemption)
- Breakthrough Device Designation Application
- FDA communication regarding medical device submission requests and review questions
- Materials preparation for meetings with FDA including briefing packages, presentations, and executive summaries.
Our Services
- Biopharmaceutical Consulting
- Medical Device Consulting