Gaining the right product approvals and certificates for major markets is fundamental for succeeding and ensuring the safety and effectiveness of every medical device. No one wants to spend all day wading through countless spreadsheets, or digging through file cabinets to locate registration data. Regulatory Affairs Manager is built specifically for the management and tracking of product details needed for product registration and post market surveillance. It provides a quick and easy way to help users prepare, submit, approve and manage submission data seamlessly and efficiently. Regulatory Affairs Manager digitizes and institutionalizes best practices for managing the product lifecycle from planning to market authorization.
Global regulatory bodies have long pointed to incomplete or low-quality submissions as a reason for slowdowns associated with the clearance/approval of new products. By formulating a successful global regulatory strategy and automating the collection of information required in submissions (for example, U.S. FDA 510(k), PMA), medical device companies can bring products to market with greater speed and efficiency. Regulatory Affairs Manager handles global medical device market registration clearance processes, device identification records and publication for product release.
Regulatory Affairs Manager handles the medical device identification record and registration processes electronically to the FDA GUID through the entire journey— from review and approval workflows to prevent production errors and product recalls. Safety monitoring and compliance is an integral part of the management of medical devices.Regulatory Affairs Manager offers a single global solution with powerful automation and productivity tools to meet the challenges of managing your worldwide safety information. It will create, manage and report serious adverse event and product compliance cases for Electronic Medical Device Reports (eMDRs) to the FDA gateway, seamlessly and efficiently, along with other safety reports and submissions globally.
Regulatory Affairs Manager provides a robust set of compliant tools for:
- Dossier Strategy & Submission Management for Market Authorization
- Complete Device Identification Management
- Adverse Event Reporting Management