MEDCER – ULUSLARARASI MEDİKAL BELGELENDİRME ŞİRKETİ

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93/42/EEC Medical Device Directive
2017/745 Medical Device Regulation
21 CFR 820 Quality System Regulatıon

ISO 13485:2016

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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

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ISO 13485 Medical devices
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Requirements for regulatory purposes

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ISO 13485:2016
CE Marking
510(k) Fundamentals

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Biomechanical Testing
Finite Element Analyze

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