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Plan your clinical evaluation updates before the deadline pressure builds. New clinical evidence, PMS findings and PMCF results can all affect your clinical evaluation. Keeping your CEP and CER current means assessing what has changed, understanding its implications and ensuring the updates remain aligned with risk management and your wider technical documentation. Clinical360™ gives you ongoing access to clinical and regulatory specialists who help manage that process. We review new evidence, identify where updates are needed and plan upcoming activities; helping you prepare for regulatory and Notified Body questions throughout the device lifecycle. Choose a tailored scope with an agreed fixed fee, from periodic reviews and targeted guidance to broader outsourcing of clinical evidence management. You gain clarity on the support included, the work planned and the costs involved. For manufacturers without a dedicated internal clinical team, Clinical360™ provides specialist expertise and continuity while helping reduce the pressure on regulatory and quality colleagues. Make clinical evaluation a planned part of your product lifecycle. Explore Clinical360™ and discuss the right level of support for your organization.

𝐃𝐨 𝐲𝐨𝐮 𝐧𝐞𝐞𝐝 𝐲𝐨𝐮𝐫 𝐟𝐢𝐫𝐬𝐭 𝐂𝐄𝐏 𝐚𝐧𝐝 𝐂𝐄𝐑, 𝐨𝐫 𝐚 𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐫𝐞𝐛𝐮𝐢𝐥𝐝 𝐨𝐟 𝐞𝐱𝐢𝐬𝐭𝐢𝐧𝐠 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧? Our fixed-fee service covers the agreed scope from clinical evaluation strategy through literature search and appraisal, SOTA assessment, clinical data analysis, benefit-risk evaluation and final documentation. Receive your completed CEP and CER within six weeks of providing all required input documentation. Our former Notified Body reviewers, clinical specialists and medical writers are ready to help. ➡ Contact us to discuss the possibilities.

Do you have an existing Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) but need confidence in their completeness and alignment? Know where your CEP and CER need attention, and what to do next. For a fixed price, Qserve reviews your documentation against MDR requirements and Notified Body assessment expectations. Receive a gap assessment report and a practical remediation plan with detailed steps within two weeks of providing all required input documentation. Clear findings. Practical next steps. A one-time fixed fee.

Work with former Notified Body reviewers, clinical specialists and medical writers to assess, develop or maintain your clinical evaluation documentation. Choose the support your medical device needs: ✔CEP/CER Gap Analysis ✔Complete CEP/CER Development ✔Clinical360™ for ongoing tailored support Whether you need an independent review, a complete CEP and CER or continuous lifecycle support, Qserve provides a clear scope, predictable costs and practical clinical evaluation expertise. Explore the services and find your fit.

Plan your clinical evaluation updates before the deadline pressure builds. Clinical360™ provides ongoing support to maintain your CEP and CER, assess new evidence and connect updates with PMS, PMCF and risk management. We also plan upcoming updates and prepare for regulatory and Notified Body questions. Choose a tailored scope for a fixed fee that fit your organization, from periodic assistance to broader clinical evidence management. Get specialist support, without building a dedicated internal clinical team.

Preparing your device and UDI data for EUDAMED? If you also supply devices in Switzerland, your registration work does not end there. Two deadlines are approaching: 𝟐𝟖 𝐍𝐨𝐯𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟔 for applicable legacy-device registrations in EUDAMED, and 𝟑𝟏 𝐃𝐞𝐜𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟔 for the end of the Swissdamed transition period. Qserve can help you structure and validate your data, then manage submissions to both databases. Sign up for our EUDAMED legacy bulk upload support before 1 October, and 𝐰𝐞’𝐥𝐥 𝐡𝐚𝐧𝐝𝐥𝐞 𝐲𝐨𝐮𝐫 𝐒𝐰𝐢𝐬𝐬𝐝𝐚𝐦𝐞𝐝 𝐝𝐞𝐯𝐢𝐜𝐞 𝐮𝐩𝐥𝐨𝐚𝐝 𝐟𝐫𝐞𝐞 𝐨𝐟 𝐜𝐡𝐚𝐫𝐠𝐞. The offer ends soon. Contact us to discuss your portfolio and secure the offer.