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.
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.
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.
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 and Competent Authorities. Our commitment to quality and precision is unwavering.
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.
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.
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.
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 and Competent Authorities. Our commitment to quality and precision is unwavering.
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 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 DeSia, 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.
• Quality Management Systems that ensure your operations meet and exceed international standards.
• Regulatory Compliance Consulting to navigate the complex regulations in global markets.
Medical Device manufactureres who requires testing will benefit from the services offered by our laborotory:
Stability
Medical devices are analyzed to determine the physical effects on the sterile barrier system under aging conditions. The information obtained after aging procedures determines the expiration date of medical device sterile barrier systems.
Packaging Integrity Tests
Testing package integrity is essential for assessing the sterility and shelf life of a medical equipment or product. Package integrity testing includes tests such as visual, tensile, burst, sealing width as specified in the EN ISO 11607 standard series.
Transport Simulation Tests
Transport studies provide a consistent framework for assessing the resistance of products to the distribution environment in the laboratory. This is performed by putting products through a test plan that includes a series of estimated hazards experienced during different distribution cycles.
Stability
Medical devices are analyzed to determine the physical effects on the sterile barrier system under aging conditions. The information obtained after aging procedures determines the expiration date of medical device sterile barrier systems.
Packaging Integrity Tests
Testing package integrity is essential for assessing the sterility and shelf life of a medical equipment or product. Package integrity testing includes tests such as visual, tensile, burst, sealing width as specified in the EN ISO 11607 standard series.
Transport Simulation Tests
Transport studies provide a consistent framework for assessing the resistance of products to the distribution environment in the laboratory. This is performed by putting products through a test plan that includes a series of estimated hazards experienced during different distribution cycles.
DeSia offers guidance in usability area so that you can conduct your most comprehensive usability study. It also ensures that the data is collected and reported as stated in EN 62366.
