What is Clinical Data according to MDR? What is Clinical Data according to MDR?
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What is Clinical Data according to MDR?
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Clinical Trials Clinical Trials
Clinical Studies
Clinical Trials
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Documents Proving Security and Performance Documents Proving Security and Performance
Documents Proving Security and Performance
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Precision in Every Step of Clinical Affairs

At DeSia, we specialize in delivering customized solutions throughout your clinical journey. Our dedicated team, proficient in every facet of clinical affairs, ensures excellence from Clinical Evaluation Plans/Reports to Post-Market Clinical Follow-up, and from strict Clinical Trial Design to comprehensive Clinical Trial Reports. We blend expertise with regulative requirements in every document, application, and statistical analysis we undertake.

Expertise in Regulatory and Quality Compliance

We understand the nuances of each clinical and scientific studies, the significance of regulatory requirements like MDR or IVDR compliance, assuring your clinical and preclinical activities are not only thorough but also strategically aligned with current regulations.

Collaborative Clinical Data Collection and Analysis

Collecting and analyzing clinical data for your medical devices is a crucial process, now more critical than ever. Let us guide you in selecting the most suitable studies for your device, designing impactful research, and employing advanced statistical methods for both planning and analysis phase.

A Legacy of Success in Clinical Studies

DeSia stands tall with a proven track record of successfully navigating diverse clinical studies across a broad spectrum of products, earning approvals from numerous Certification Bodies in Turkey and Europe. Our commitment to quality and precision is unwavering.

Comprehensive Support for Your Clinical Studies

With DeSia, you gain a partner ready to support every phase of your clinical study. Whether it's crafting detailed protocols and reports, managing the difficulties of clinical study execution, or conducting thorough audits to ensure your studies are on the right track. Our expert team is equipped to guide you to success.

DESIA CLINICAL
Services
Clinical Evaluation
Clinical Evaluation
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Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) Studies
Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) Studies
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Summary of Safety and Clinical Performance (SSCP)
Summary of Safety and Clinical Performance (SSCP)
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Clinical Studies
Clinical Studies
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Regulatory Consultancy
Regulatory Consultancy
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Clinical Trial Audit
Clinical Trial Audit
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Trainings
Trainings
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Performance Evaluation
Performance Evaluation
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Biocompatibility Evaluation and Strategy: Ensuring Device Safety and Compliance
Biocompatibility Evaluation and Strategy: Ensuring Device Safety and Compliance
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Comprehensive Medical Device Development and Regulatory Services
Comprehensive Medical Device Development and Regulatory Services
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Library Posts

Articles

SSCP Preparation for Implantable and Class III Devices
SSCP Preparation for Implantable and Class III Devices
Basic Information about Clinical Trials
Basic Information about Clinical Trials
MDR Planning
MDR Planning
GSPR Article 10.4
GSPR Article 10.4
Chemical characterization - Overview
Chemical characterization - Overview
Chemical Characterization – Medical Device Configuration
Chemical Characterization – Medical Device Configuration
Designated EU Reference Laboratories for Class D Devices
Designated EU Reference Laboratories for Class D Devices
Clinical Studies for Medical Devices
Clinical Studies for Medical Devices
Clinical Data According to the MDR
Clinical Data According to the MDR
Effects of MDR on CE Certified Medical Devices in Terms of Clinical Data
Effects of MDR on CE Certified Medical Devices in Terms of Clinical Data
Medical Device Clinical Research
Medical Device Clinical Research
Fundamental Information About Clinical Trials
Fundamental Information About Clinical Trials
DESIA CLINICAL

Strategic Solution Partners

AdviQual
AdviQual

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Opera (Tigermed)
Opera (Tigermed)

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Koç University Hospital
Koç University Hospital

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HealthCarePoint
HealthCarePoint

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Eurofins
Eurofins

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