Achieving quality objectives is a continuous journey... Achieving quality objectives is a continuous journey...
Achieving quality objectives is a continuous journey...
Services
Have you analyzed your Clinical Data for MDR? Have you analyzed your Clinical Data for MDR?
Have you analyzed your Clinical Data for MDR?
Evidence documents for Safety and Performance
Have you performed your Clinical Data analysis as per EU 745/2017 MDR? Have you performed your Clinical Data analysis as per EU 745/2017 MDR?
Have you performed your Clinical Data analysis as per EU 745/2017 MDR?
Clinical Data Management
Do you know that you can get our services for both clinical and regulatory document requirements? Do you know that you can get our services for both clinical and regulatory document requirements?
Do you know that you can get our services for both clinical and regulatory document requirements?
DeSia Clinical Research
ADVIQUAL
Services
Quality Management System (QMS) Establishment
Quality Management System (QMS) Establishment
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MDR Complaint Technical File Preparation
MDR Complaint Technical File Preparation
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Risk Management
Risk Management
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Clinical Data
Clinical Data
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Design Control
Design Control
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Biocompatibility Documentation
Biocompatibility Documentation
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Validation
Validation
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Regulatory Strategy
Regulatory Strategy
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Training

AdviQual Training Fields

ISO 14971 Risk Management & MDR
  • B. Baranoğlu Demirci
  • Ö. Özen
ISO 14971 Risk Management & MDR
Clinical Evaluation & MDR
  • P. Nebol
  • Ö. Özen
  • B. Baranoğlu Demirci
Clinical Evaluation & MDR
MDR QMS (ISO 13485) & MDSAP
MDR QMS (ISO 13485) & MDSAP
EU 2017/746 IVDR General
  • B. Baranoğlu Demirci
  • Ö. Özen
EU 2017/746 IVDR General
Technical File Preparation according to 2017/746 IVDR
  • B. Baranoğlu Demirci
Technical File Preparation according to 2017/746 IVDR
Usability
  • Ö. Özen
Usability
EU 2017 / 745 MDR
  • B. Baranoğlu Demirci
EU 2017 / 745 MDR
EU 2017/745 MDR Technical File Preparation
  • B. Baranoğlu Demirci
EU 2017/745 MDR Technical File Preparation
Articles
Library Posts
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GSPR Article 10.4.
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UDI or Basic UDI?
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News
AdviQual News
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06.11.2021 14:00
MEDICA 2019
We can assist your team through stringent global standards and regulations with OUR deep expertise in Quality Management...We can assist your team through stringent global standards and regulations with OUR deep expertise in Quality Management...
15.09.2021 12:00
The 2nd World Congress on RAMD
Başak Baranoğlu Demirci attended the 2nd  World Congress on Regulatory Affairs for Medical Devices...Başak Baranoğlu Demirci attended the 2nd  World Congress on Regulatory Affairs for Medical Devices...
11.11.2020 12:00
Expomed Eurasia
AdviQual is ready to provide services in order to facilitate readiness for the implementation of Medical Device Regulation...AdviQual is ready to provide services in order to facilitate readiness for the implementation of Medical Device Regulation...
16.09.2020 12:00
Training at Turkish Medicines and Medical Devices Agency (TMMDA)
We organized another training for employees of Turkish Medicines and Medical Devices Agency...We organized another training for employees of Turkish Medicines and Medical Devices Agency...
05.08.2020 14:00
Med-Tech Innovation Expo UK
AdviQual is ready to provide services in order to facilitate readiness for the implementation of Medical Device Regulation...AdviQual is ready to provide services in order to facilitate readiness for the implementation of Medical Device Regulation...
18.06.2020 12:00
Seminar about MDR
Many different companies participated in our seminar which was held at Istanbul Technical University Arı Teknokent conference hall...Many different companies participated in our seminar which was held at Istanbul Technical University Arı Teknokent conference hall...
23.10.2019 16:00
LICENSALE.COM® Roadshow & Briefing UDI
Benny Arazy, Arazy Group CEO, was hosted in Istanbul and Ankara. Benny Arazy, visiting Turkey within the scope of East Roadshow...Benny Arazy, Arazy Group CEO, was hosted in Istanbul and Ankara. Benny Arazy, visiting Turkey within the scope of East Roadshow...
18.05.2017 12:00
MDR News
A new nomenclature system is almost ready for medical devices to support the EUDAMED system under the Medical Device Regulation...A new nomenclature system is almost ready for medical devices to support the EUDAMED system under the Medical Device Regulation...
ADVIQUAL

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