Quality and Compliance

Regulatory Affairs Manager ()

Regulatory Affairs Manager manages global medical device market registration and submissions for marketing clearance, device identification records, and publication for product release. It manages global adverse events including the electronic submission of eMDR (Electronic Medical Device Reporting) to the FDA and manual submission to global health authorities.

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Regulatory compliance creates unique challenges within the healthcare and life sciences industry and needs to become an integral part of the medical device lifecycle.  Gaining the right product approvals and certificates for major markets is fundamental for ensuring the safety and effectiveness of every medical device. No one wants to spend all day wading through countless documents 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 the medical device identification record and registration processes electronically to the FDA GUID through the entire journey— from gathering the data, review to publication. The solution expanded capabilities for DI traceability and submission creates a holistic approach to integrating data across the organization.

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 a company’s worldwide safety information. It creates, manages and reports 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.

Key features & benefits

  • Complete coverage of the regulatory landscape; including product registration and tracking, submission management and document management

  • Complete end-to-end UDI submission solution and global regulatory submission tracking all submissions and approvals for market approval or UDI submissions with capacity for thousands of products and hundreds of countries

  • Provides a number of tools that are specifically designed to streamline the production of compliant regulatory dossiers

  • Organizations get to regulatory approval faster with accurate submissions, which can also be reused for submissions to many different regulatory bodies

  • Offering the richest and most powerful tools to enable the rapid creation, review and submission of regulatory dossiers

  • Global Market Registration guides users in the collection of all relevant information required by the regulatory agency

  • Templates streamline all data entries including D.I. attributes associated with the “unit of use” for each product. They must be managed across multi-level packaging hierarchy configurations to support enterprise use of this critical data.

  • A robust streamlined and traceable UDI submission management.

  • Streamline submission with developed templates for things such as; Workflow templates and submission templates (IDE,PMA,510K,CE)

  • Regulatory Submission Templates for consistent complete submissions and approvals in all countries

  • Reduce time-to-market with complete UDI Management and Dossier Management from creation and beyond

  • Manage Language requirement