Kalypso to be acquired by Rockwell Automation, Inc. (NYSE: ROK). Read the press release.
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.
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.
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.
Document Sharing to IMDRF Table of Contents
Formatting, Rendering & Printing
Secure Distributor & Dealer Collaboration
Country-Specific Package Templates
Submission Workflow Automation
Integration to External systems (e.g. ERP shipping flags)
Enterprise System Integration including PLM, SCM, FSM, ERP