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 templates that align with your branding and device type/classification, ensuring every submission is consistent, audit-ready, and compliant with MDR/IVDR structure and content requirements. We can develop every type of document template, from SOPs to CERs, making sure to include embedded guidance text and reviewer checklists.
We create training programmes that can be designed for medical writers, regulatory affairs teams, quality specialists or any other role within your company. 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, literature review procedures, evidence appraisal, regulatory frameworks and the new ISO 18969.
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.