Celegence Launches AI-Assisted CER Authoring in CAPTIS^®, Reducing Drafting Effort by Up to 80% Across Select CER Sections

AI-assisted authoring reduces drafting effort by 75% to 80% for selected CER sections while preserving expert oversight, source traceability, and regulatory rigor.

CHICAGO, September 15, 2026 — Celegence, a global regulatory consulting and technology company, today announced the availability of AI-enabled Clinical Evaluation Report (CER) authoring within its CAPTIS^® platform, helping manufacturers accelerate MDR-compliant CER development while maintaining expert oversight, traceability, and regulatory rigor. Celegence combines technology and regulatory expertise to deliver EU MDR-compliant documentation more efficiently and cost-effectively.

Across live CER projects, Celegence has observed a 75% to 80% reduction in drafting effort for selected CER sections using AI-assisted authoring, enabling medical writers to focus more on evidence evaluation, scientific interpretation, and regulatory strategy.

The new capability supports AI-assisted first drafts for well-defined CER content areas, grounded in validated sources such as literature review evidence and manufacturer-held technical documentation. All AI-generated content is fully traceable to source evidence. Celegence’s medical writers direct, review, and finalize every draft to ensure alignment with notified body expectations.

“AI has the potential to transform regulatory medical writing, but only when combined with the right controls and domain expertise. With AI-enabled CER drafting in CAPTIS^®, we’re helping manufacturers accelerate MDR-compliant deliverables while maintaining the traceability, quality, and regulatory rigor they expect. Clinical interpretation, conclusions, and regulatory accountability remain firmly in the hands of our regulatory and medical writing experts,” said Sonia A. Veluchamy, Chief Executive Officer at Celegence.

AI-assisted drafting is already being used in live CERs delivered by Celegence’s medical writing teams. Supported sections include device overview, manufacturer and regulatory context, applicable standards, design and development history, and summaries of existing nonclinical, preclinical, and manufacturer-held clinical data.

“Manufacturers need MDR-compliant CERs delivered faster without compromising quality. By combining AI with Celegence’s regulatory expertise, CAPTIS^® helps clients reduce effort, accelerate timelines, and achieve compliance with greater confidence,” said Cheryl Jessen, Chief Revenue Officer at Celegence.

Celegence is now extending these capabilities to the State of the Art (SoTA) discussion and Device Under Evaluation (DUE) summary sections. SoTA has historically been one of the most challenging components of a CER because it requires synthesizing evidence across hundreds of scientific publications rather than summarizing known internal data.

CAPTIS^® can now generate structured, traceable first drafts across key SoTA subsections, including clinical background, alternative treatment options, applicable guidelines and recommendations, and summaries of safety and performance evidence for the DUE and identified similar devices. Based on internal evaluations, Celegence anticipates that AI-assisted drafting for the SoTA and DUE sections could reduce authoring effort by approximately 50%. Additional efficiencies are expected as the technology matures and continues to benefit from regulatory expert feedback.

Unlike standalone AI writing tools, CAPTIS^® embeds agentic AI directly into regulated CER workflows. These multi-step processes retrieve, extract, and synthesize evidence across source documents before generating a structured draft. Manufacturers benefit from accelerated delivery without having to deploy, validate, or govern AI internally. Outputs are generated within a secure, closed environment designed for regulated use and are subject to a human-in-the-loop review process led by experienced CER authors. This approach enables faster drafting while maintaining full traceability between generated content and supporting evidence.

“We’ve embedded agentic AI directly into regulated CER workflows to accelerate evidence synthesis and first-draft creation. This allows our experts to spend less time on manual authoring and more time on clinical evaluation, scientific interpretation, and regulatory decision-making,” said Punya Abbhi, Chief Operating Officer at Celegence.

AI-enabled CER drafting represents an important milestone in Celegence’s broader innovation journey. Building on this foundation, Celegence continues to invest in technologies that make regulatory knowledge more accessible, reusable, and actionable, helping organizations create high-quality regulatory content more efficiently across products and projects.

About Celegence

Celegence is a technology-enabled regulatory partner for medical device, pharmaceutical, and in vitro diagnostic manufacturers.

Celegence combines deep regulatory expertise with proprietary AI to help organizations streamline regulatory operations, accelerate the development of compliant documentation, and maintain audit-ready quality across the product lifecycle. From regulatory strategy and clinical evaluation through post-market maintenance, Celegence’s experts and AI-enabled solutions help manufacturers improve efficiency, consistency, and regulatory outcomes.

Recognized on the 2025 Inc. 5000 list of America’s fastest-growing private companies, Celegence helps regulatory and clinical teams maintain audit-ready compliance while improving operational efficiency.

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