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Quality Policy
Quality Objectives
References
OUR SERVICES
ISO 13485 Quality Management System
Installation of the appropriate infrastructure and guidance
2017/745/EU Medical Device Regulation (MDR) Preparation of Technical File for CE Marking/Certification
Medical Device Risk Management
Process Validations
Clinical Evaluation
Post Market Surveillance (PMS)
Biological Evaluation
Usability
Software Validation
MDR
Introduction to MDR
MDR Requirement
What Does MDR Bring?
Common Specifications
Clinical investigations
How is Clinical Research Conducted?
Where is Clinical Research Conducted?
For Which Devices Are Clinical Trials Mandatory?
Who is the Sponsor/Supporter in Clinical Trials?
Clinical Trial Duration?
Clinical Trial Costs?
Provision of Volunteer Patients?
Voluntary Patient Insurance Status?
Are clinical trials required for MDR transition for products that have been marketed with existing MDD documentation?
Post-Market Surveillance System (PMS)
PMS Report
Periodic Safety Update Report (PSUR)
Summary of Safety and Clinical Performance (SSCP)
Post-Market Clinical Follow-up (PMCF)
Reporting of Serious Adverse Events and Field Safety Corrective Actions
Trend Reporting
UDI Codes
UDI consists of UDI-DI and UDI-PI
Implant Card
European Database (EUDAMED) Records
European Representative/Authorized Representative
Person Responsible for Compliance with Legislation
Product Damage Compensation Insurance
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WHAT IS MEDICAL DEVICE CE MARKING AND CE CERTIFICATION?
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