iProcess Global Research is a key player in advancing healthcare through medical device trials. Our role is essential in transitioning medical devices from concept to clinical application, focusing on rigorous testing and systematic categorization to ensure safety and efficacy.
Medical Device Classification
- Class I Devices: Low-risk instruments like tongue depressors, with general controls for safety.
- Class II Devices: Moderate to high-risk devices such as infusion pumps, requiring special controls.
- Class III Devices: High-risk devices like heart valves, demanding pre-market approval for utmost safety.
Phases of Medical Device Clinical Trials
- Preliminary Trials: Testing for safety and functionality in controlled settings.
- Phase I Trials: Initial human testing focusing on safety and performance.
- Phase II Trials: Expanded population studies for in-depth safety and efficacy analysis.
- Phase III Trials: Large-scale testing across diverse demographics for comprehensive evaluation.
- Post-Market Clinical Follow-Up Trials: Ongoing performance monitoring in real-world applications.
Adapting to Technological Innovations
iProcess is pioneering in the “software as a medical device” (SaMD) category, integrating AI for drug discovery and disease diagnosis. We offer digital imaging and clinical pathology services, adapting trial methodologies to include data accuracy and digital security.
Global Regulatory Standards
Adhering to international regulations like the FDA and EU’s MDR, we ensure compliance across diverse markets, understanding the global impact of medical device trials.
Meeting Modern Challenges
We address the challenges of integrating digital technologies with traditional devices, focusing on both mechanical safety and data integrity.
Partner with iProcess
Join iProcess Global Research in shaping the future of medical devices, where innovation meets safety. Our expertise in medical device trials is critical in enhancing patient care and advancing healthcare technologies.
Partner with us to make a difference in the medical world.
