Clinical Investigation for Medical Devices Clinical Investigation for Medical Devices
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Accredited Testing for Transport Simulation (ASTM D4169) Accredited Testing for Transport Simulation (ASTM D4169)
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Integrated Solutions for Medical Device Regulation

At DeSia, we offer clear and reliable support throughout your clinical and regulatory journey. From clinical evaluations, PMCF activities and clinical trial design to statistical analysis and reporting, we ensure every step is fully aligned with current regulatory expectations. We help you choose the right study design, plan effectively and manage documentation with precision. Our team has broad experience across various medical device types and has successfully supported many approvals by Notified Bodies and Competent Authorities.

We believe that with the right expertise and partner, even the most complex challenges can be solved through simple and effective solutions. Beyond clinical affairs, we provide expert consulting in quality systems, regulatory compliance, validation and technical documentation preparation. Our accredited laboratory offers testing services including stability, packaging integrity and transport simulation to verify the safety and robustness of your devices. We also guide usability studies and support biocompatibility strategies. With DeSia, you gain a reliable partner focused on clarity, compliance and results, helping you bring safe and effective devices to market.

 

DESIA CLINICAL
Services
Clinical Affairs
Clinical Affairs
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Biocompatibility Evaluation
Biocompatibility Evaluation
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Regulatory and Quality Consultancy
Regulatory and Quality Consultancy
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Testing
Testing
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Usability
Usability
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Validation
Validation
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Trainings
Trainings
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Library Posts

Articles

Video Library
Video Library
Clinical Investigation for Medical Devices – The Clinical Investigation Plan
Clinical Investigation for Medical Devices – The Clinical Investigation Plan
Biological evaluation of medical devices
Biological evaluation of medical devices
SCHEER 2024 CMR ED Phthalate General Overview
SCHEER 2024 CMR ED Phthalate General Overview
Chemical characterization – Cohorts of Concern (CoC) & Analytical Evaluation Threshold (AET)
Chemical characterization – Cohorts of Concern (CoC) & Analytical Evaluation Threshold (AET)
Chemical Characterization – Worst-case chemical release
Chemical Characterization – Worst-case chemical release
Chemical characterization – Chemical equivalence
Chemical characterization – Chemical equivalence
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
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
DESIA CLINICAL

Strategic Solution Partners

AdviQual
AdviQual

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Tigermed
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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