MDR:2017/745
One of the most important issues that medical device manufacturers, importers and economic stakeholders have been interested in in recent times is the future of the sector with MDR. Regulation on Medical Devices (MDR) (EU 2017/745), Medical Devices Directive (MDD) (93/42 /EEC) and Active Implantable published in May 2017 MDR, which is used as an acronym for the Regulation on Medical Devices (AIMD) (90/385 / EEC), actually brings with it very important responsibilities for the medical device industry.
Who should participate?
- Management Staff, Product Managers, Employees of organizations obliged to comply with MDR
- Management Staff, Product Managers, Employees to transition from MDD to MDR
- Those who want to know a basic level about MDR,
- Those who want to specialize in MDR,
- Those who want to consult on MDR,
- Those who want to be instructors in MDR.
- MDR Personnel/Personnel
- Quality Assurance, Quality Control Personnel/Personnel
- Production, Clinical and R&D Personnel/Personnel
- Important dates in the transition process
- Topics to help you determine your roadmap and strategy during the migration process
- What you need to know about products in accordance with MDR (MDR 2017/745/EU) rules
- Issues you need to change as medical device manufacturers with MDR
- Medical Device description
- Medical Device Classification
- Risk Management Process
- PMS & PMCF
- New communication with Certification Bodies
- Clinical Data Evaluation
- Clinical Research Requirement
- Creation of technical files and documentation for your Medical Device
- Safety and Performance Requirements of Medical Device
- Importance of quality management system in regulation of Medical Devices
- EUDAMED
- UDI
