Comprehensive Clinical Study & Evaluation for Medical Devices
- Clinical Evaluation Report (CER) preparation as per EU MDR 2017
- Clinical trials for medical devices as per ICMR, CDSCO, EU MDR, and ICH-GCP guidelines
What is a Clinical Evaluation Report (CER)?
CER is a regulatory document required under EU MDR to demonstrate the safety and performance of medical devices.
Do you conduct clinical trials for medical devices?
Yes, we conduct clinical studies in compliance with ICMR, CDSCO, EU MDR, and ICH-GCP guidelines.
Are your services aligned with EU MDR requirements?
Yes, we provide CER preparation and clinical studies aligned with EU MDR 2017 regulations.
Do you support regulatory submissions?
Yes, we provide submission-ready clinical data and documentation for regulatory approvals.
Can you support global clinical requirements?
Yes, our services are aligned with international regulatory frameworks for global market access.
Clinical Evidence. Confident Outcomes.
Clinical studies are essential to demonstrate the safety, performance, and clinical benefits of medical devices. At Accuprec, we provide comprehensive clinical evaluation and trial services aligned with global regulatory requirements.
Our expertise includes preparation of Clinical Evaluation Reports (CER) as per EU MDR 2017 and execution of clinical trials for medical devices in accordance with ICMR, CDSCO, and ICH-GCP guidelines.
With a strong focus on regulatory compliance and clinical evidence generation, we deliver reliable and submission-ready data to support approvals across global markets.
Our Approach to Accurate & Compliant Testing
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
