SERVICES Medical devices
Quality management
systems
Requirements for
regulatory purposes
93/42/EEC Medical Device Directive
2017/745 Medical Device Regulation
21 CFR 820 Quality System Regulatıon
DETAILS ISO 13485:2016
SERVICES ISO 13485 Basic Training
ISO 13485 Lead Auditor Training (Accredited)
2017/745 Medical Device Regulation Training
ISO 14971 Risk Management in Medical Devices Training
Sterilization Methods and Validation Training
DETAILS TRAINING
SERVICES Biomechanical Testing
Finite Element Analyze
DETAILS TESTING
SERVICES USA Product Registration DETAILS USA Product Registration SERVICES CE Marking & Technical Documentation DETAILS CE Marking &
Technical Documentation
SERVICES Clinical Evaluation DETAİLS CLINICAL EVALUATION
SERVICES

CERTIFICATION

ISO 13485 Medical devices
Quality management systems
Requirements for regulatory purposes

SERVICES

TRAINING

ISO 13485:2016
CE Marking
510(k) Fundamentals

SERVICES

TESTING

Biomechanical Testing
Finite Element Analyze

SERVICES

CONSULTANCY for US Regulations

510(k) Submissions
Product Registrations
U.S. Agent Services

SERVICES

CONSULTANCY for EU Regulations

Design Dossiers Documentation
Technical File Documentation

SERVICES

CONSULTANCY for Clinical Evaluation

Clinical Evaluation
Post Market Clinical Follow-Up Study
Clinical Trial

CERTIFICATE EXPLORER

To navigate certification validity

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HUMAN RESOURCES

Medcer Open Positions