In this episode we’re proud to welcome Dr. Bassil Akra. We are discussing the MDR – the new regulation and changes to come seen from the side of the Notified Body and touch on important topics such as Technical Documents, new reports such as SPUR and SSCP and use of clinical evidence from equivalent products for low risk class products.
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Clinical Data & Analytics
Clinical Evaluation Report
Clinical Investigation for Medical Devices
Clinical Research Organisation
Clinical Trial Management
Clinical Trial Management Systems
Clinical Trial Services
Data Management
PMCF Studies
Post-Market Studies
Clinical Development
Clinical Evidence Strategy
Clinical Study Design
Clinical Trial Regulatory Requirements
EU MDR Consulting
ISO 13485 Consulting
ISO Standards for Clinical Research
IVDR Consulting
Medical Device Classification
Medical Device Regulatory Strategy
Post-Market Surveillance
PSUR
Quality Management
Risk Management
Technical Documentation
UDI & EUDAMED
