Having an experienced, in-house regulatory affairs team at ERI Group helps position your product for success throughout the process. Working directly with your team, we will help to develop and manage your regulatory strategy, while collaborating with the necessary internal partners at ERI Group to achieve commercial launches. With deep experience in all device classifications, risk levels, and system complexities, our team is ready to help you navigate all aspects of regulatory affairs.
Set your project up for regulatory success
Capabilities
- Global regulatory and clinical strategy development
- Global regulatory filings and registrations
- Regulatory strategy, filing pathway definition and identification of data for submissions
- Regulatory issue mitigation
- Lead interactions with FDA, Notified Bodies, and other regulators
- Pre-submission processes to de-risk regulatory actions, breakthrough device designation processes