# CER-QA.AI: Clinical evaluation with AI Compliant. Efficient. Reliable. We create Clinical Evaluation Reports for medical devices: researched with AI, a source for every statement, reviewed and signed by an experienced CER expert. - You provide your product documents – we deliver the signature-ready CER. - Per MDR (EU) 2017/745 & MEDDEV 2.7/1 Rev. 4. - No months of lead time: handing over 3–4 working days before your deadline is enough. - **3–4 working days** including expert review and release - **> 80%** Proven process with a first-pass rate of over 80% - **€10,000\*** Start-up promo price per CER \* Guide price. We confirm the binding fixed price after reviewing the risk class, scope and documents. All prices plus VAT. ## How your CER is made In six steps – per MDR (EU) 2017/745 and MEDDEV 2.7/1 Rev. 4: - **Intake** Product data, intended purpose, indications and user groups are entered once and used in all chapters. - **Literature** PubMed search with a documented search protocol, AI-assisted selection of relevant articles, appraisal of the level of evidence. - **State of the art** Draft of the current state of the art and comparable products – with sources from the search. - **Vigilance** FDA MAUDE and recalls as well as BfArM field safety notices, with links. - **Complaints** Your complaint data is analyzed and included qualitatively and quantitatively. - **Report** Word document in CER format with a reference list. Missing data is flagged, not invented. ### Principles - Every statement has a source – or it is flagged as an open point. - The language model runs locally. Your data does not go to a public cloud. - Every version is archived with its date and data state. - A CER expert reviews, completes the assessments and signs. ## Price & ROI Calculate your advantage in seconds. Compare classic consulting costs with CER-QA.AI. Adjust the values to your situation. ## Consulting When data or clinical evidence is missing, we support you before and after CER creation. Consulting is an additional service, not included in the CER price, and can be booked separately – quote on request. - **Strategy consulting** Evidence and approval strategies for legacy devices and new developments, support with Notified Body queries. - **Gap analysis** Review of your documents and identification of data gaps. - **Document optimization** Revision of insufficient input documents. - **PMCF & studies** Design of measures to close evidence gaps, e.g. PMCF activities. ## Mission We significantly reduce your bureaucratic workload and streamline internal processes all the way up to certification - **Compliant.** Per MDR and MEDDEV 2.7/1 Rev. 4. Every statement sourced, every report reviewed and signed by a CER expert. - **Efficient.** The AI takes over the repetitive work. Your report is ready in days instead of months. - **Reliable.** No transfer errors, traceable sources. What is not proven is flagged – not invented. ## Founding team ### PD Dr. med. Ulrich Matern Medicine & Regulatory Affairs Physician and scientist. 40 years in medical technology. 14 years of CER practice with a first-pass rate of > 80%. Experienced reviewer for Notified Bodies. Reviews and signs the reports. ### Henry Rasenack Technology & Operations System architect of CER-QA.AI. Over 20 years of project and company leadership in international plant construction, including 3 years as CEO. Many years of work for clients in the pharmaceutical and chemical industries. ## Investor relations CER-QA.AI is in its founding phase. The first commercial project is complete, and further products are in development. For conversations with investors, reach us at info@cer-qa.ai. ## News - **Oct 2026: Premiere at Medical Valley Hechingen** First public presentation of the live workflow to an expert audience from QM and regulatory affairs. - **Oct 2026: First project with a MedTech manufacturer** Processing time for complex reports cut from several weeks to two days. ## Contact - Email: info@cer-qa.ai - Phone: +49 176 41667872 - Address: Orthalden 163, 87474 Buchenberg, Germany - [Contact form](https://cer-qa.ai/#contact) - [Legal notice](https://cer-qa.ai/impressum/) - [Privacy policy](https://cer-qa.ai/datenschutz/) Note: The first-pass rate of over 80% refers to our founder's previous CER practice.