Fryderyk Janiak

Pure Clinical: Your End-to-End R&D and Regulatory Partner in MedTech About Us Pure Clinical is a specialized Contract Research Organization (CRO) and Regulatory Consultancy (formerly known as MDR Regulator). We offer a unique, integrated approach to the MedTech industry, supporting manufacturers throughout the entire product lifecycle—from early concept and regulatory planning to clinical investigations and post-market activities. As a designated Research & Development (R&D) Centre, we do more than just execute projects; we develop forward-looking solutions that help manufacturers translate scientific innovation into compliant, market-ready products. Our Track Record 303+ Satisfied Clients 512+ Completed Projects 148+ Clinical Trials Conducted 230+ Successfully Completed Certifications 37+ Global Regions Covered Core Service Areas Medical Device & IVD Certification: A complete pathway to the CE Mark under MDR (2017/745) and IVDR (2017/746). We integrate regulatory strategy with clinical evidence generation to accelerate development and reduce certification risks. Our team specializes in high-risk Class III devices and complex innovative technologies. Quality Management Systems (QMS): Implementation and auditing of ISO 13485 and ISO 17025, including gap audits, supplier evaluations, and internal audits to ensure robust and compliant systems. Clinical Trials & CRO Services: From feasibility assessments and site selection to clinical data management. We manage studies in accordance with ISO 14155 and GCP, providing evidence of safety and performance under real clinical conditions. Software & AI (SaMD): We have vast experience with Software as a Medical Device (SaMD), navigating the intersection of EN 62304, MDR/IVDR, and the EU AI Act. We ensure that digital health innovations meet all modern safety, lifecycle, and regulatory requirements. Global Registration & Market Access: Based in Warsaw, Poland, we collaborate with international partners to support global manufacturers entering the EU and European innovators expanding internationally (EU, UK, US, Canada, Switzerland, and LATAM). The Pure Clinical Advantage R&D Center Status: Our status allows clients to access significant benefits, including up to 80% in EU/national funding and up to 40% tax benefits for R&D activities. Unified Expertise: We act as a strategic partner, integrating regulatory affairs and clinical research under one roof to eliminate the gap between clinical data and technical documentation. Industry Insiders: Our multidisciplinary team consists of experts with "Notified Body" mindsets, focusing on problem-solving, concept validation, and responsiveness. Let’s Connect We are looking to collaborate with: Medical device and IVD manufacturers and MedTech start-ups. Regulators from around the world looking to partner on local regulations or aid their clients with gathering clinical data through our referral-based model. Distributors and strategic partners seeking regulatory and clinical support. Research institutions interested in clinical investigations.