DeSia Clinical provides strategic solutions in quality systems (ISO13485), regulatory and clinical affairs, clinical trials, and design testing to meet the diverse needs of our clients across medical and in vitro diagnostic devices.

With our different team of consultants, we provide a comprehensive range of services to support our clients throughout their products' lifecycle.

Our core Services are

• Setting up ISO 13485 QM System
• Preparing Technical Files for MDR / IVDR
• Preparing Clinical documents to prove the safety and performance of the devices (CEP, CER, BEP, BER, PMCF, SSCP)
• Preparing application documents of a Clinical Trial (Protocol, CRF, ICF, IB, Safety Plan, Monitoring Plan, Submission forms etc.)
• Verifying design control
• Validating operational processes
• Testing Package integrity and Transportation simulations
• Preparing Usability documents
• Performing Software Validation and CyberSecurity

We are committed to delivering reliable, organized, and proven services to our clients, where quality, compliance, and client satisfaction are prioritized.

You may receive the knowledge, professional resources, and expertise needed to succeed in the competitive medical industry.