We offer specialised services in clinical consulting, medical writing, documentation support and bespoke training for medical device manufacturers to achieve compliance with global regulatory requirements, with a focus on EU MDR/IVDR.
Proven Experience
The Consultants at Clinera Solutions have supported the preparation of over 250 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.
With an academic background of Clinical Microbiology, along with over a decade of experience in the industry covering class I to III devices, ensures that every project receives the same scientific approach 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.
Our team attends and presents in industry conferences and seminars for the continued learning and shared knowledge among other experts, ensuring we are always up to date with the latest changes and news relevant to best practices, both in medicine and within regulatory affairs.
Collaborative and Transparent Approach
Clients are kept closely informed throughout each stage of development, from scoping and planning, through literature review and drafting, to final submission, with defined review points and clear communication throughout.
We determine key stages to communicate updates for each project, as well as provide clear feedback on our analysis of set criteria at each stage in order to provide context along the collaboration with our clients.
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.