Medical Devices

Medical devices and durable medical equipments

• Preparation of Technical Documentation based on manufacturer input and documents in accordance with MDR (2017/745) or IVDR (2017/746) requirements
• Our key project-based focus areas within the technical documentation include:

1. 1. Clinical evaluation according to MDR (plan, analysis, State of the Art, report, etc.)
   2. Biological evaluation (according to ISO 10993) – plan, analysis, report
   3. Proper preparation of PMS/PMCF plans and reports
   4. Preparation of SSCP
   5. Preparation of PMSR for Class I devices
   6. Preparation of PSUR
   7. Preparation of GSPR
   8. Development of usability documentation

• We regularly participate as a working group in our partners’ risk assessment processes, including the preparation and review of plans and reports
• As an experienced team in the development of medical devices, we collaborate with our manufacturing partners to ensure all activities are performed in compliance with regulations, and we also take on the preparation of appropriate reports for each development phase – for example, we perform preliminary biological/biocompatibility evaluations of selected raw materials according to standards from the earliest stages
• In case of material changes, we similarly support selection, preliminary evaluation, and preparation of documentation required by notified bodies for approval
• We prepare QMS documentation according to ISO 13485 from scratch, adapted to the manufacturer – including the writing of specified and compliant procedures, forms, work instructions, and manuals
• We provide preparation support and internal audits for our partners to achieve ISO 13485 certification
• Adaptation of ISO/ASTM 52920 into existing QMS for manufacturing processes involving 3D printing
• EUDAMED registration, NOR registration, full knowledge of manufacturer/distributor/importer/authorized representative responsibilities – consulting and preparation of documentation
• Consulting on UDI code and labeling requirements
• PRRC responsibilities and provision of responsible person – offered only to long-term partners with whom we have established mutual cooperation and communication
• Provision or support of QMS management
• Clinical investigations – CRO tasks (e.g., clinical investigation plan, monitoring, clinical protocol, etc.)
• Determination of risk classification with full reasoning and justification according to MDR
• Through our joint development, we have created MDR/IVDR support software with a partner company to ensure MDR compliance, with a special focus on UDI traceability, and a separate solution to support NOR registration