Services offered by M Squared Associates
M Squared Associates provides the full range of services required throughout the FDA approval/clearance process, including:
- Regulatory strategy and project planning
- Pre-submission meetings with FDA
- Preclinical study planning
- Clinical study design
- Institutional Review Board (IRB) applications
- 510(k) Premarket Notifications
- Investigational Device Exemptions (IDE's)
- Premarket Approval Applications (PMA's)
- Investigational site qualification and study initiation
- Clinical study management, including monitoring and audits
- Data analysis and presentation
- FDA Advisory Panel Meeting preparation and presentation
- Post-approval requirements