Kalypso acquired by Rockwell Automation, Inc. (NYSE: ROK). Read the press release.

Enhance your device regulatory strategy and accelerate global registrations

To compete and grow in a global market, medical device companies must be able to scale international sales – quickly. This means developing products that meet diverse customer needs, comply with global regulations and adhere to country-specific submission processes.

However, today’s complex and constantly changing regulatory environment makes it challenging to manage global product registrations. A robust regulatory information (RIM) strategy can help to reduce significant risk for your business so you can focus on driving global growth instead.

The Imperative for Better Regulatory Information Management

In addition to the evolving regulatory landscape, manual business processes, complex enterprise ecosystems and resource constraints make it challenging for companies to manage their international registrations.

Medical device companies can transform how they manage regulatory information with a globally unified product registration process that streamlines the tasks of regulatory resources. When enabled by integrated product lifecycle and quality management systems, your organization can gain a global source of truth by connecting regulatory registration information with product data in a traceable way.

Common Regulatory Challenges in Medical Device

  • Companies don’t know where products are registered, or when they need to be re-registered
  • Registration tracking systems are siloed and disconnected from product data systems
  • Constant change in global regulations is requiring increased scrutiny and need for renewal on a per-country basis
  • Limited resources are available to staff international registration efforts

Key Capabilities of Regulatory Information Management

  • Plan which products to register in which countries, by when, by whom, etc.
  • Improve searching, reporting and auditing features to analyze cycle times, spot trends, and identify problems
  • Integrate with master product data and provide downstream systems with information to control salability and shipping
  • Execute and submit submission packages efficiently using country-specific templates, formatting, rendering, and advanced collaboration and content management features
  • Track agency correspondence, registration status by part number and location, expiration dates, certificates, licenses and more

Download our RIM eBook

RIM e Book cover

Watch the RIM webinar

Screen Shot 2019 11 22 at 2 10 42 PM

Rapidly Build Regulatory Information Management Capabilities with Accel for RIM

This why we built Accel for Regulatory Information Management (RIM) - to provide a single, global source of truth for product registration planning and tracking to accelerate regulatory submissions.

Accel for RIM is an integrated platform that enables medical device companies to more effectively manage product registrations and comply with regulations via an accelerated, leading-practice delivery model.

Using a data-driven approach that leverages digital product connectivity enabled by a modern RIM system, Accel for RIM is designed to quickly implement foundational regulatory information management capabilities to help companies manage, control and report regulatory data.

Accel for RIM is pre-configured and based on industry-leading practices.

Business Impact

  • Expand and accelerate international sales – reduce time, effort and expertise required to register products; know where products are registered and salable
  • Reduce regulatory risk – prevent shipment of unauthorized or non-compliant products; understand the impact of design changes; respond quickly to changing regulations; know where to report adverse events or conduct product recalls
  • Make better decisions – improve planning and strategic decisions with better information
  • Reduce manual effort of strained resources – free people to focus on higher value work
RIM Ecosystem

Accel for RIM Foundational Capabilities

Registration Planning & Tracking

Country-Specific Registration DataStatus by Part Number & Sellable LocationPart-Specific Registration Data

Dependency Management

Agency CorrespondenceContent ManagementDeclarations, Certificates, & LicensesWorkflow Automation
Effective & Expiry DatesNotifications & SubscriptionsAdvanced Searching & ReportingRegulatory Compliance
Role-based Security & ApprovalsPart 11 Compliant SignaturesFull Audit Trail & History

Registration Execution & Submission

Document Sharing to IMDRF Table of Contents

Formatting, Rendering & Printing

Secure Distributor & Dealer Collaboration

Electronic Submissions

Country-Specific Package Templates

Submission Workflow Automation

Integration to External systems (e.g. ERP shipping flags)

Enterprise System Integration including PLM, SCM, FSM, ERP

Accel Advantages

  • "Production-ready" software system with leading-practice functional capabilities
  • Leading-practice, pre-defined security model
  • Minimal configuration effort
  • Swift user adoption by leveraging out-of-the-box capabilities and prepared training materials
  • Pre-defined, reusable attributes and workflows for faster time to deploy – lower cost of ownership