EU & UK Medical Device Regulations and Compliance
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20 Modules
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Live Executive Programs
Accreditation Earned: EU & UK Medical Device Regulations and Compliance
This certified program will provide you with actionable insights into EU & UK MDR compliance, quality management, and clinical standards to ensure market success and product safety.
Key skills you will gain:
- Medical Devices Directive (MDD)
- UK MDR 2002
- Medical Devices Regulations (MDR) Compliance
- IVDR Understanding
- Device Classification
- Risk Assessment
- Quality Management
- UK UDI Systems Management
- ISO 13485 Compliance
- ISO 14971 Application
- Clinical Evaluation
- Regulatory Submissions
- UK Approved Bodies Navigation
- Quality Management Systems (QMS)
- Notified Body Interaction
- Technical Documentation
- Post-Market Surveillance
- Adverse Event Reporting
- EUDAMED Data Management
- Clinical Development Plan (CDP)
- Declaration of Conformity (DoC)
- Post-Market Clinical Follow-Up (PMCF)
- Unique Device Identification (UDI) System
- Person Responsible for Regulatory Compliance (PRRC)
- CE (Conformité Européenne) Marking
- UKCA Marking
- Field Safety Corrective Actions (FSCA)
- Conformity Assessment
- MHRA Registration
- Standard of Care (SoC)