Streamline MDR & IVDR Document Creation with CAPTIS™
In the intricate world of medical device and in vitro diagnostic regulations, meticulous documentation is paramount. Celegence provides cutting-edge technology solutions tailored to assist medical writers, reviewers, and managers in improving compliance and efficiency.
How CAPTIS Can Streamline Your Document Creation
For Medical Writers: Experience unprecedented efficiency with advanced automation such as integrations with literature databases, automatic capture of article metadata, and dedicated workflows for state-of-the-art content creation – designed to streamline your processes, while features such as AI-enabled data extractions and systematic literature review summaries enhance your research endeavors.
For Reviewers: Collaborate seamlessly across teams with features such as commenting, simultaneous reviews, and incorporation of sequential document review workflows. Streamline content verification with easy linking to source documents, ensuring accuracy and completeness.
For Managers: Gain enhanced project visibility and data control, ensuring ownership and access to project data. Simplify compliance with easy template updates based on Notified Body feedback, and improve quality by ensuring consistency across reports using data dictionaries and auto-filling report document content. CAPTIS™ also facilitates easier maintenance and knowledge management through a centralized repository with prior versions, history, and an audit trail.
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
Significance of Regulatory Compliance
Sonia Veluchamy, CEO of Celegence, emphasizes the significance of regulatory compliance:
“At Celegence, we recognize the critical importance of regulatory compliance in the life sciences industry. Our cutting-edge platform, CAPTIS™, empowers regulatory compliance professionals with transparency, consistency, and reusability. Combined with our extensive expertise in medical writing, we deliver an unparalleled end-to-end solution to keep your post-market surveillance documentation on track.”
Efficient MDR & IVDR Document Creation
In a world where precision is paramount, CAPTIS™ by Celegence emerges as your ultimate ally, elevating regulatory excellence. Celegence, founded by Sonia Veluchamy, provides regulatory operations and assistance with Efficient MDR & IVDR Document Creation. For more information or to explore how CAPTIS can revolutionize your team, email us at info@celegence.com or contact us online.
