True compliance depends on more than just documentation. Clinera Solutions helps organisations build internal competence through bespoke tools, templates, and training tailored to their workflows, device types, and regulatory maturity.
We develop custom templates that align with your branding, device classification, and internal review structure, ensuring every submission is consistent, audit-ready, and compliant with MDR/IVDR structure and content requirements. Templates can be built for CERs, CEPs, PMS reports, risk documentation, or technical file components, with embedded guidance text and reviewer checklists.
Our training programmes are designed for medical writers, regulatory affairs teams, and quality specialists. Sessions can be delivered virtually or in person (Europe only), and are always adapted to your company’s existing processes and documentation. Topics include clinical evaluation methodology, evidence appraisal, regulatory writing standards, and MDR/IVDR awareness.
Our MDR templates, tools, and training support includes:
Other 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.