Does the company have experience with medical device studies under MDR?
Yes. Biostat® has extensive experience in conducting medical device clinical investigations in accordance with EU Regulation 2017/745 (MDR) and ISO 14155:2020. Thanks to our interdisciplinary team — covering regulatory affairs, biostatistics, project management and clinical monitoring — we provide full-service support from concept to CE certification.
Our services include:
• Development of the Clinical Investigation Plan (CIP) and complete study documentation (CIP, patient information and consent forms, monitoring plan, quality management plan, statistical plan, SOPs, safety documentation).
• Submission management for Bioethics Committees and URPL, including preparation, filing, follow-up and addressing authority questions.
• Full project management and monitoring, including site activation, staff training, reporting, quality oversight and data supervision via modern systems (eCRF, eTMF, CTMS).
• Data analysis and preparation of the Clinical Investigation Report (CIR) compliant with MDR Annex XV and ISO 14155.
• Preparation of CER, SSCP and PMCF documentation for CE certification, including updates of technical documentation and QMS integration.
We support both pre-market and PMCF studies across device classes I–III and work with manufacturers, distributors and importers adapting to MDR requirements.
Biostat® combines scientific rigor with regulatory compliance, ensuring that clinical evidence supports CE marking and market access.
