MDR & compliance
Read more about the services, we provide
•CE-Mark MDR EU 2017 745, ISO 13485:2016, Classification, technical documentation, Labeling and UDI, registrations EUDAMED, PMS
•Clinical evaluation report: driving the process and documentation
•Risk Management, driving the cross functional workshop to evaluate and complete the risk management report
•Post-Market Surveillance. Develop the process monitoring of quality, complaints, customer feedback, continuous improvements and relevant stakeholder communication
•UDI - Develop UDI portfolio overview, develop the structure, process and integration in the business process
•Labeling & packaging: Intended use and claiming, instruction for use, storage and handling
•Instruction for use: Developing the instruction for use with a cross functional team, managing localization in all languages
•Market Access: Support markets with regulatory document, pricing and reimbursement strategy and with Health Technology assessment with clinical benefit and cost effectiveness, value proposition and economic modeling
•Engage with Authorities: registration at EUDAMED report with documentation in Australia, UK and other markets outside EU
