Medical Devices

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At Axcellant, we pride ourselves on our extensive expertise and unwavering commitment to advancing the medical devices sector through meticulously conducted clinical studies.

Our skilled team of professionals brings together a wealth of experience garnered over numerous successful projects, ensuring we deliver exceptional, reliable services every time.

medical devices

Axcellant is experienced in the following types of studies

Clinical Investigations with Medical Devices

Pilot Studies: Laying a solid foundation for your medical device project.

Pivotal Studies: Robust investigations to ascertain the effectiveness and safety of your medical device.

Post-Market Clinical Follow-up (PMCF): Continuous assessment post-market to ensure ongoing safety and performance.

Registry Studies and Surveys: Extensive data collection to understand real-world performance and patient experiences.

In Vitro Medical Device Studies

Performance Studies: Assessing the functionality and reliability of in vitro medical devices.

PMCF: Ensuring sustained performance and safety in a real-world setting.

Medical Devices Experience

Our Track Record

Successfully executed 42 medical device studies to completion, showcasing our capability to handle projects of varying complexities.

Currently steering 4 ongoing medical device studies with a hallmark of precision, ensuring each study is on track to meet its objectives.

Enrolled over 3,100 patients in medical device studies, reflecting our ability to manage large-scale studies effectively.

Demonstrated excellence through 11 audits and 2 rigorous inspections in medical device studies, underlining our commitment to adhering to the highest industry standards.

Our Services

Clinical Trial Design and Management: We offer comprehensive clinical trial design and management services to ensure well-planned, executed, and monitored clinical studies.

Regulatory Submission Support: Our team provides robust support for regulatory submissions, aiding in the preparation of documentation necessary for regulatory approvals.

Data Management and Statistical Analysis: Employing state-of-the-art data management systems and statistical analysis methods to ensure accurate and reliable results.

Clinical Monitoring: Ensuring adherence to protocol and regulatory requirements through meticulous monitoring of clinical sites.

Our approach is to work in close collaboration with our clients, providing a tailored service that meets the unique needs of each project.

We uphold a high standard of integrity, transparency, and excellence in every aspect of our work, ensuring your medical device project is in capable hands from inception through to completion.

Discover how Axcellant can be the catalyst for your medical device project’s success. Dive deeper into our services and let’s discuss how we can support your medical device clinical studies.

Services

Newsroom

Key Considerations for Initiating a Clinical Trial: A Comprehensive Guide

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Completion of a significant clinical study

Our team at Axcellant is proud to announce the completion of a significant Post-Market Clinical Follow-up study. This study was…

Unveiling Real-World Evidence in Clinical Trials

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