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Tigermed-Jyton and TAYA Zhiyan Launch CER Smart-Gen AI-empowered clinical evaluation, creating a brand-new solution

During the preparation of registration application materials for medical devices, the writing of the Clinical Evaluation Report (CER) has always been a complex undertaking that relies heavily on professional judgment and meticulous execution. As a leading Chinese medical device CRO under Tigermed, Tigermed-Jyton has deepened its expertise in this service for many years, possessing strong professional advantages. Recently, Tigermed-Jyton, in collaboration with TAYA Zhiyan, launched an intelligent CER document writing platform—CER Smart-Gen. By integrating the high efficiency of AI productivity with professional expertise in medical devices, it has established an efficient and transparent intelligent CER writing workflow, providing innovative solutions for CER writing to the industry and comprehensively safeguarding the clinical evaluation, registration application, and full lifecycle compliance management of medical devices.

Deepening Expertise in the CER Field: Building a Solid Foundation with Professional Accumulation

Clinical evaluation of medical devices is conducted by the registration applicant to demonstrate the product's conformity to the essential principles of safety and performance. The result of the clinical evaluation is the Clinical Evaluation Report (CER), which can be submitted to regulatory authorities for review. The clinical evaluation report elaborates in detail on clinical data and its quality, demonstrating how clinical data proves that the product conforms to the essential principles of safety and performance. Tigermed-Jyton has been deeply engaged in the field of CER drafting for over ten years, having efficiently delivered more than 430 medical device clinical evaluation reports. These cover NMPA domestic registration and EU MDR compliant CERs, with business coverage spanning more than twenty medical fields such as cardiovascular, orthopedics, endocrinology, surgery, dentistry, reproduction, imaging, and neurology, providing high-quality services to many of the world's TOP 30 medical device enterprises.

The Tigermed-Jyton CER team has accumulated a good market reputation through rigorous and objective technical comparisons, systematic and comprehensive literature retrieval and screening, precise data extraction and adverse event aggregation, professional statistical analysis, and high-quality medical writing capabilities. The solid professional capabilities accumulated over many years have also become a firm foundation for Tigermed-Jyton 's exploration of intelligent CER tools.

Facing Industry Challenges: Exploring Paths to Improve Efficiency

Drafting a compliant medical device clinical evaluation report requires constant switching between complex technical documents, item-by-item extraction and comparison, line-by-line identification of equivalence and differences, and the aggregation of evidence related to product efficacy and safety from massive amounts of literature. Issues such as scattered information, repetitive labor, difficulties in maintaining consistency, and time-consuming content verification are common challenges that the industry has long faced.

Tigermed believes that the solution to these challenges is not simply to replace human judgment with technology, but to let tools handle repetitive tasks, allowing professionals to focus on higher-value analysis and decision-making. Based on this philosophy, Tigermed, in collaboration with TAYA Zhiyan, developed the CER Smart-Gen, positioned as a professional tool for assisting in document organization, content generation, and process management.

CER Smart-Gen: Letting Professional Tools Serve Professional Judgment

CER Smart-Gen is a pure web-based SaaS product that requires no complex installation; users can create projects, upload documents, and start writing directly in a browser. Centered on the core processes of CER for same-type products, the platform integrates seven specialized writing tools:

·       Comparison Table Drafting: Extract information such as scope of application, technical characteristics, and biological properties from the documentation of the product under application and the comparable product, intelligently analyze differences in comparison items, and generate an adjustable comparison table.

·       Summary and Determination of Differences: Based on the generated comparison table, summarize the difference items and assist in forming the determination content.

·       List of Scientific Evidence for Difference Sections: Following the difference items, organize corresponding supporting documents and evidence leads.

·       Clinical Data Summary Table: Extract basic information from the clinical documentation of the product under application/comparable product according to preset or custom fields.

·       Qualitative Description of Clinical Literature: Form structured literature descriptions focusing on research objectives, methods, results, and conclusions.

·       Quantitative Analysis of Efficacy: Summarize clinical performance and efficacy outcomes using text and charts.

·       Quantitative Safety Analysis:<g type="tag1" text="/tag">Textual and graphical summaries of AE/SAE/complaints and other safety outcomes.

Content generated by the platform's intelligent tools supports traceability to the original text and highlights the location in the source document; multiple generation results will not directly overwrite each other, allowing authors to compare and verify first before deciding whether to incorporate them into content blocks. All AI-generated content can be saved to the "AI Generated" module and, after manual editing and modification, supports phased saving as historical versions. As explicitly stated in the platform instructions: CER Smart-Gen is used to assist in document organization, content generation, and process management, but still requires professionals with appropriate qualifications and experience to conduct clinical evaluation, evidence judgment, and final review.

Flexible service models to meet the needs of different teams

CER Smart-Gen offers four flexible service models tailored to the staffing of different teams, project complexity, and delivery requirements:

l  Model 1: AI Writing – Clients independently use the CER Smart-Gen platform to complete data parsing, variable extraction, generation via seven AI writing modules, source verification, and content revision. This model is designed for enterprise teams that already possess mature CER writing and review capabilities, allowing them to fully integrate internal expertise with tool efficiency to maximize comprehensive advantages.

l  Model 2: AI Writing + Manual Review – Professional manual review is added on top of the AI-generated draft to systematically verify key variables, outputs from each module, and report content. By cross-checking with source documents to ensure the authenticity, completeness, accuracy, and consistency of information, this model balances delivery efficiency with content reliability.

l  Model 3: Expert Consultation Enhanced Model (Fully Managed CER AI + Consultation) – The Tigermed-Jyton expert team completes CER writing and delivery for clients based on the CER Smart-Gen platform. Clients do not need to purchase AI Smart-Gen platform licenses and can select expert consultation services based on project complexity or needs. The expert consultation service is provided by Tigermed-Jyton’s senior medical and regulatory affairs experts with extensive industry experience. They deeply integrate product characteristics, clinical application scenarios, and actual submission requirements to formulate one-on-one clinical evaluation and regulatory strategies, providing full-process support for product clinical evaluation, regulatory submission, and lifecycle compliance management.

l  Model 4: Traditional Manual CER Writing Service – For clients who have concerns about using AI tools or whose management policies do not yet permit AI-assisted drafting, Tigermed-Jyton can provide traditional fully manual expert drafting services. Senior medical and regulatory affairs experts undertake the full-chain technical services for clinical evaluation and regulatory submission.

From tools to systems, promoting the accumulation of industry knowledge

The value of the CER Smart-Gen is not only reflected in improving the writing efficiency of individual reports, but also in its long-term benefits. It can assist enterprises in gradually establishing a standardized writing system and accumulating exclusive knowledge assets. As projects continue to accumulate, project materials, enterprise templates, key variables, abbreviations, metric definitions, common tables, and historical project experience can be transformed into reusable assets, forming a sustainable and reusable intelligent writing system. The Smart-Gen is continuously expanding clinical research and registration document scenarios, promoting the reuse of key information and consistency management across different documents, moving medical writing from one-time delivery to a content production system that is accumulative, collaborative, and traceable.

We always believe that the value of technology lies in serving professionalism. CER Smart-Gen is an innovative empowerment of professional capabilities—allowing professionals to save time on data organization and structured writing, and devote more energy to clinical evaluation strategy judgment and evidence control work.