Case Study

Medical Writing Support for Ophthalmological Devices

Project Summary

A leading manufacturer of eye-care and vision-care products, including ophthalmologic surgical devices, partnered with Celegence for medical writing support to ensure EU MDR compliance across its portfolio. The engagement covered the creation and maintenance of clinical evaluation and post-market surveillance documentation for 40 device families, supporting compliance for Class I, IIa, IIb, and III devices.

Scope of Work

Celegence has supported the client’s EU MDR compliance efforts for over five years by taking ownership of:

MDR compliance support for 40 ophthalmological device families

Coverage of Class I, IIa, IIb, and III devices

CEP, CER, LSRR, PMCF, and PMS documentation ownership

NB observation management and audit remediation

Long-term collaboration spanning five years

Project Deliverables

Creation and maintenance of Clinical Evaluation Plans and Reports (CEP/CER)

Development of Literature Search and Review Reports (LSRRs)

Authoring Post-Market Clinical Follow-up Plans (PMCFP) and PMS Reports

Assessing the adequacy of clinical evidence and identifying new or emerging risks based on product history, pre-clinical and clinical studies, complaints, adverse events, and published literature

Responding to Notified Body (NB) observations and remediating documentation following NB audits

Project Achievements

>98% quality and on-time delivery performance, despite tight timelines

Improved MDR compliance through expert regulatory guidance

Project Success

The success of this long-term partnership has been driven by strong communication with the manufacturer’s clinical affairs team, a clear understanding of evolving regulatory expectations, adaptability to changing submission schedules, and the therapeutic-area expertise of Celegence’s medical writing team.

Need Ongoing MDR Medical Writing Support for Your Device Portfolio?

Celegence provides scalable, long-term medical writing and PMS support to help manufacturers maintain MDR compliance across complex and evolving device portfolios. 📧 Email us at info@celegence.com

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Contact Us Today

From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.

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Medical Writing Support for Ophthalmological Devices​