Medical Devices – Performance Evaluation
Ensuring Safety, Reliability and Compliance Through Comprehensive Testing
The performance evaluation of medical devices is a crucial step in ensuring their safety, effectiveness, and regulatory compliance before market approval. At CRONET, we provide a full range of services to support preclinical and clinical performance assessments, helping companies meet international standards while optimizing their development timelines.
Our tailored approach ensures that testing and validation processes align with each device’s specific design, intended use, and regulatory requirements reducing risks and streamlining approvals.
Preclinical Performance Evaluation
We conduct in-depth functionality, usability, and safety assessments in laboratory settings before clinical trials. Our goal is to identify potential early risks, verify design specifications and ensure compliance with regulatory expectations.
Performance Testing & Verification
We coordinate and oversee mechanical, electrical, and functional testing in accordance with international standards, verifying that each device meets the necessary performance and safety criteria. Our team ensures testing is conducted efficiently, with accurate reporting and documentation to support regulatory submissions.
Clinical Performance Studies
Generating robust clinical evidence is essential real-world safety and effectiveness. We assist in the design and planning of clinical performance studies, ensuring they meet regulatory and ethical requirements while delivering reliable data.
Post-Market Surveillance & Performance Monitoring
Medical device performance doesn’t stop at market approval. We provide continuous monitoring and post-market surveillance services, collecting and analyzing real-world data from users, healthcare professionals and regulatory bodies. This proactive approach helps identify early potential safety concerns, ensuring compliance with evolving regulations.
Why Choose CRONET?
Expert Guidance
Decades of experience in medical device evaluation and regulatory compliance.
Tailored Strategies
Customized approaches based on device classification and intended use.
End-to-End Support
From early-stage assessments to post-market monitoring.
Regulatory Compliance
Alignment with MDR, IVDR, FDA, and ISO 17025 requirements.