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ISO 13485 Quality Management System
Installation of the appropriate infrastructure and guidance
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93/42/EEC Medical Device Technical Files
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Introduction to MDR
MDR Requirement
What Does MDR Bring?
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Clinical investigations
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
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UDI consists of UDI-DI and UDI-PI
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HOMEPAGE
CORPORATE
About Us
Quality Policy
Quality Objectives
OUR SERVICES
ISO 13485 Quality Management System
Installation of the appropriate infrastructure and guidance
Process Validations
93/42/EEC Medical Device Technical Files
Medical Device Risk Management
Clinical Evaluation
Post Market Surveillance (PMS)
Biological Assesment
Software Validation
Usability
MDR
NEW
Introduction to MDR
MDR Requirement
What Does MDR Bring?
Common Specifications
Clinical investigations
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
Authorised Representative
Product Damage Compensation Insurance
TRAININGS
REFERENCES
CONTACT US
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