Watermark's strategy for post market safety surveillance is designed to meet the needs of companies large or small. We can serve as the safety reviewers for all cases that are reported to a company or we can support the safety department’s efforts. It is important to consider several aspects of safety surveillance:
- Gathering reports (MDR, FDA 3500, CIOMS)
- Reviewing reports for safety concerns
- Reporting to regulatory authorities
Watermark can support all aspects of gathering information from physicians, reviewing safety concerns and assisting with report creation for regulatory authorities.