We offer specialised medical consulting services, medical writing services, and documentation support for medical device manufacturers, with a focus on EU MDR/IVDR compliance and global regulatory requirements.
Proven Experience
Clinera Solutions has supported the preparation of over 150 Clinical Evaluation Reports (CERs), along with over 100 Post Market Surveillance (PMS), Periodic Safety Update Report (PSUR) and Post Market Clinical Follow-up (PMCF) plans and reports, covering 33 types of devices across 10 therapeutic areas. From Class I to Class III, every project receives the same scientific depth and regulatory precision.
Expert Understanding of MDR and MEDDEV Requirements
All documentation aligns with MDR (EU) 2017/745, MEDDEV 2.7/1 Rev. 4, and the latest MDCG guidance. The focus is not only on compliance, but on ensuring your evidence is clearly structured and ready for notified body review.
Collaborative and Transparent Approach
Clients are kept closely informed throughout each stage of development, from scoping and literature review to final submission, with defined review points and clear communication.
Our Services
Why choose us?
At Clinera Solutions, expertise is built into every document delivered. Each project benefits from years of hands-on experience in clinical and regulatory writing, with a focus on accuracy, efficiency, and clear clinical storytelling.