Contract Research Organization (CRO) Services for Medical Devices & IVD
We offer a full-scope solution to support your clinical investigational trial needs, from developing clinical strategies and writing clinical protocols to executing clinical trials, conducting PMCF surveys, and writing clinical evaluations.
Clinical Evidence Generation in a High-Stakes Regulatory Landscape
Clinical Evidence Generation in a High-Stakes Regulatory Landscape
Global regulatory expectations for medical devices and IVDs continue to intensify. Whether navigating EU MDR/IVDR, FDA requirements, or other international frameworks, manufacturers must now demonstrate safety, performance, and clinical benefit with unprecedented transparency throughout the entire product lifecycle. Designing compliant studies that align with ISO 14155 and Good Clinical Practice (GCP) can quickly strain internal resources and delay market access.
Without a specialized clinical strategy, companies risk:
- Data gaps that delay regulatory submissions
- Protocol deviations that weaken evidence quality
- Post-market compliance findings from Notified Bodies
- Costly process in CE marking and global market entry
A Specialized Medical Device CRO
We are a specialized Contract Research Organization exclusively serving medical device and IVD manufacturers. We conduct clinical studies within all therapeutic areas.
Our approach combines deep regulatory expertise with hands-on clinical operations to help you design, execute, and report studies that meet global requirements. We act as a seamless extension of your team, translating complex MDCG guidelines and regulatory expectations into practical, audit-ready clinical solutions.
Comprehensive CRO Services
PMCF Surveys
Post-market clinical Follow-Up (PMCF) surveys have become essential for medical device manufacturers in an increasingly regulated medical world. They provide insights into the performance and safety of devices in real-world settings and ensure compliance with regulatory requirements such as the EU MDR and FDA.
PMCF Studies (Prospective & Retrospective)
We manage the complete lifecycle of PMCF studies, including protocol development, ethics submissions, site identification, investigator engagement, data collection, and final reporting. Our approach ensures your device's continued safety and performance are documented with scientific integrity.
IVD Clinical Performance Studies
We design and execute IVD clinical performance studies to demonstrate the accuracy, reliability, and clinical value of your diagnostic device. For stand-alone IVD products and for companion diagnostics (CDx) connected to a drug trial. Our team ensures your study generates robust data to support regulatory approval and long-term success.
Clinical Trials
We conduct full-scope clinical studies, observational, pivotal, pilot or randomized studies in a all therapeutic areas. As a leading contract research organization, we specialize in providing comprehensive services supporting the successful design, development, execution, and management of clinical trials.
Clinical Registries
We support your device lifecycle end-to-end so you can generate reliable, real-world evidence with speed and compliance.
Clinical Training
We specialize in equipping clinical teams with the skills and insights they need to navigate the complexities of clinical trials while maintaining regulatory compliance.
Poorly planned or inadequately managed clinical programs are the leading cause of delays in MedTech. Protocol deviations, slow enrollment, inconsistent data quality, and regulatory findings don't just increase costs. They weaken the evidence value and risk rejection by Notified Bodies.
Our Regulatory-Driven Approach:
Proactive Risk Management – We identify potential site bottlenecks, enrollment challenges, and data quality risks before they impact timelines.
Scientific Rigor – Every clinical objective, endpoint, and data collection method is directly linked to your regulatory and commercial goals.
Operational Agility – We utilize structured project management frameworks to keep studies efficient, compliant, and inspection-ready for regulatory audits.
Poorly planned or inadequately managed clinical programs are the leading cause of delays in MedTech. Protocol deviations, slow enrollment, inconsistent data quality, and regulatory findings don't just increase costs. They weaken the evidence value and risk rejection by Notified Bodies.
Our Regulatory-Driven Approach:
Proactive Risk Management – We identify potential site bottlenecks, enrollment challenges, and data quality risks before they impact timelines.
Scientific Rigor – Every clinical objective, endpoint, and data collection method is directly linked to your regulatory and commercial goals.
Operational Agility – We utilize structured project management frameworks to keep studies efficient, compliant, and inspection-ready for regulatory audits.
FAQ – Medical Device & IVD CRO Services
Still have questions? We are here to help, including with clinical strategy support.
How does a specialized MedTech CRO differ from a pharmaceutical CRO?
Traditional CROs are optimized for pharmaceutical drug trials. We specialize exclusively in medical devices and IVDs, with deep expertise in PMCF, MDR/IVDR requirements, ISO 14155, device-specific clinical investigations, and the iterative nature of MedTech product development.
Do you support both pre-market and post-market clinical evidence generation?
Yes. Our services span the entire product lifecycle—from initial clinical investigations for CE marking and FDA submissions to post-market clinical follow-up (PMCF), safety surveillance, and long-term registry management.
Which global regulatory standards do your clinical programs follow?
All clinical activities align with MDR (EU 2017/745), IVDR (EU 2017/746), ISO14155:2020, GCP (ICH E6), and MDCG guidance documents. We also adapt strategies to meet FDA, Health Canada, TGA, and other regional requirements for global market expansion.
Can you act as an extension of our internal clinical team?
Absolutely. We offer flexible CRO engagement models—from complete end-to-end study management to targeted consulting, staff augmentation, and clinical training—tailored to your internal capabilities and resource needs.