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

Welcome to AdviQual - Pioneering Healthcare Consulting

At AdviQual, we are more than consultants; we are your strategic partners in the healthcare industry's future. Founded in 2015, AdviQual has quickly risen to become a beacon of innovation and excellence in the medical device and in vitro diagnostic device sectors. Our mission is to empower manufacturers with the knowledge, strategies, and tools needed to navigate the complex landscape of healthcare regulations and market demands successfully.

AdviQual specializes in a comprehensive suite of consulting services designed to address the critical areas of quality management, regulatory compliance, testing and validation, and clinical data management. Our approach is not just about meeting standards but setting them. With AdviQual, you gain access to:
• Quality Management Systems that ensure your operations meet and exceed international standards.
• Regulatory Compliance Consulting to navigate the complex regulations in global markets.
• Product Testing and Validation that proves the efficacy and safety of your products.
• Clinical Research Design and Management to generate compelling evidence of your product's value and effectiveness.

In collaboration with our sister companies, DeSia and NioReg, AdviQual offers an unparalleled spectrum of services that cover every stage of the product development process. From conceptualization to market entry, our integrated solutions provide a seamless, efficient path to success, ensuring your products not only reach the market faster but do so with a competitive edge.

• Depth of Expertise: Specialized knowledge in the medical device and in vitro diagnostic sectors.
• Customized Service: Strategies tailored to the unique needs and objectives of our clients.
• Global Compliance: Mastery of international standards and regulations.
• Result-Oriented Approach: Focused on maximizing your success in the market.
ADVIQUAL
Services
Quality Management System Consultancy
Quality Management System Consultancy
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Regulatory Strategy
Regulatory Strategy
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Technical File Preparation
Technical File Preparation
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Risk Management Services
Risk Management Services
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Clinical Documents
Clinical Documents
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Design Control Services
Design Control Services
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Biocompatibility Documentation Service
Biocompatibility Documentation Service
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Validation Service
Validation Service
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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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Chemical characterization – Cohorts of Concern (CoC) & Analytical Evaluation Threshold (AET)
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Chemical Characterization – Worst-case chemical release
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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

Testimonials

To learn more about AdviQual, please take a glance at our Clients comments.