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Biological evaluation of medical devices
25 December Wednesday 2024
Biological evaluation of medical devices
Author: Gizem Banger View Details
SCHEER 2024 CMR ED Phthalate General Overview
22 October Tuesday 2024
SCHEER 2024 CMR ED Phthalate General Overview
Author: Gizem Banger View Details
Chemical characterization – Cohorts of Concern (CoC) & Analytical Evaluation Threshold (AET)
2 October Wednesday 2024
Chemical characterization – Cohorts of Concern (CoC) & Analytical Evaluation Threshold (AET)
Author: Gizem Banger & Mohamed Yehia View Details
Chemical Characterization – Worst-case chemical release
3 August Saturday 2024
Chemical Characterization – Worst-case chemical release
Author: Gizem Banger & Mohamed Yehia View Details
Chemical characterization – Chemical equivalence
17 July Wednesday 2024
Chemical characterization – Chemical equivalence
Author: Gizem Banger & Mohamed Yehia View Details
Summary of the EU AI Act: First Regulation on Artificial Intelligence
1 June Saturday 2024
Summary of the EU AI Act: First Regulation on Artificial Intelligence
Author: Created with AI Support. View Details
Clinical Studies for Medical Devices
12 March Tuesday 2024
Clinical Studies for Medical Devices
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Clinical Data According to the MDR
12 March Tuesday 2024
Clinical Data According to the MDR
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Effects of MDR on CE Certified Medical Devices in Terms of Clinical Data
12 March Tuesday 2024
Effects of MDR on CE Certified Medical Devices in Terms of Clinical Data
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Clinical Evaluation
12 March Tuesday 2024
Clinical Evaluation
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Chemical Characterization – Medical Device Configuration
6 March Wednesday 2024
Chemical Characterization – Medical Device Configuration
Author: Gizem Banger & Mohamed Yehia View Details
Chemical characterization - Overview
18 January Thursday 2024
Chemical characterization - Overview
Author: Gizem Melis Banger & Mohamed Yehia View Details
Designated EU Reference Laboratories for Class D Devices
12 December Tuesday 2023
Designated EU Reference Laboratories for Class D Devices
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GSPR Article 10.4.
26 September Monday 2022
GSPR Article 10.4.
Author: Nurşen Erin View Details
UDI or Basic UDI?
26 September Monday 2022
UDI or Basic UDI?
Author: Özlem Özen Oğurlu View Details
Software Validation for Systems Used in Medical Device Manufacturing and Quality Systems
15 December Tuesday 2020
Software Validation for Systems Used in Medical Device Manufacturing and Quality Systems
To get general information about ISO 80002 Computer Systems Software Validation please read the article here.
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“Manufacturer Reports” Under MDR
11 August Tuesday 2020
“Manufacturer Reports” Under MDR
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Basic Information about Clinical Trials
9 April Thursday 2020
Basic Information about Clinical Trials
Whether the potential risks of a medical device are acceptable is found by comparing them with the benefits they provide for the intended use. to accu
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Personnel Responsible for Regulatory Compliance
21 February Friday 2020
Personnel Responsible for Regulatory Compliance
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Preparation SSCP for Implantable and Class III Devices
6 February Thursday 2020
Preparation SSCP for Implantable and Class III Devices
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