Envisioning the future of regulatory and medical writing, CAPTIS Copilot leverages cutting-edge AI models for the Medical Device and Diagnostic industry.

CHICAGO--(BUSINESS WIRE)--Celegence, a regulatory compliance service and software solution company, today announced the launch of CAPTIS Copilot, the most advanced document automation and literature review solution for the life sciences industry. CAPTIS Copilot is an enterprise cloud-based platform leveraging pre-trained large language models (LLM) and Reinforcement Learning from Human Feedback (RLHF) for the device and diagnostic industry. This cloud-based solution significantly advances the ability of device and IVD manufacturers to increase innovation and empower clinical, regulatory, and medical writing teams to be more strategic and productive with their time.

CAPTIS Copilot reenergizes medical writers, enhancing productivity, quality, and consistency in the creation of MDR and IVDR compliant documentation. With CAPTIS Copilot, Celegence’s own medical writing team has drastically improved the consistency and reliability of post market surveillance documentation such as scientific literature summaries, clinical evaluations, safety reports and summary of safety and performance documents. Celegence built this cloud-based software specifically for MDR and IVDR compliance, with a focus on PMS documentation including report creation and automated scientific literature reviews. A combination of both AI and traditional automation have cut the time it takes to write PMS documentation in half, allowing manufacturers to invest more time and money into delivering safe and effective products to patients.

“With the significant capabilities of generative AI technology and the advent of LLMs across a variety of industries, we have incorporated assistive artificial intelligence into compliant documentation processes in a way that is suitable for companies in the highly regulated device and diagnostic industry,” said Punya Abbhi, COO of Celegence. “With CAPTIS Copilot, we have launched the most powerful automation tool available for MDR and IVDR compliance today, using LLM for data extraction and content generation in a way that lends itself to secure, easy, and rapid implementation. We are particularly excited to partner with key clients, allowing early adoption and fine-tuning of our Copilot solution for their needs.”

Leading life sciences companies are racing to harness the impressive potential of these tools, and CAPTIS Copilot empowers the future of medical writing by creating the world’s most trusted AI assistant for regulatory compliance. Celegence has also initiated the usage of CAPTIS’ AI assistant for pharmaceutical and biologic medical writing activities, such as CCDS and SmPCs. To learn how life sciences manufacturers are reimagining the future of their medical writing workflows with CAPTIS Copilot, sign up to start a trial.

To arrange a demo, please contact a Celegence representative today at info@celegence.com or schedule your demo online.

About Celegence

Celegence helps life sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to regulatory affairs. Celegence supports life science customers in the areas of EU MDR compliance, IVDR compliance, regulatory intelligence, RIMS data management, publishing, regulatory labeling including UDI consulting, and medical writing.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management and health authority interaction. Celegence’s depth of experience and extensive delivery capabilities allow regulatory affairs and quality teams to operate more efficiently, reduce cost, and improve compliance. Our mission is to collaborate with our customers to deliver Regulatory Affairs efficiency that allows them to focus on what matters most: providing exceptional patient value. For more information, contact us online or follow us on LinkedIn.


US Contact:
Waylon Wright
Phone: +1 206-818-0636
Email: wwright@celegence.com

EU Contact:
Matthew Tyler
Phone: +44 7720969372
Email: mtyler@celegence.com

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