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Class I Medical Devices

Entering the market with a Class I medical device offers a unique opportunity due to lower regulatory hurdles, but standing out is a real challenge in a saturated space. Atlantia provides the edge you need. Our expertise in conducting efficient, targeted trials ensures your product not only complies with global standards but also carries the scientific backing to solidify its market position. We focus on user experience and safety, making your claims credible and your product desirable. Partner with us to navigate the pathway smoothly, making your market debut with confidence. Your success is built on trust and evidence, and we're here to make sure you have both.


Class II Medical Devices

For Class II medical devices, the balance between innovation and compliance is delicate. Atlantia specializes in bridging this gap. Our approach tailors clinical trials to demonstrate your device's efficacy and safety, aligning with FDA and MDR requirements. We understand the nuances of Class IIa and IIb devices, especially in the dynamic fields of cardiology and neurology, where precision matters. Our trials are designed not just for regulatory approval but to boost your product’s value in the eyes of end-users and clinicians alike. With Atlantia, your device moves beyond compliance, becoming a preferred choice for its demonstrated benefits and reliability.


Class III Medical Devices

Class III medical devices are the pinnacle of innovation and potential impact on patient care, requiring a level of scrutiny and evidence that can seem daunting. Atlantia rises to this challenge, employing our top-tier clinical research capabilities to navigate complex regulatory landscapes. We work closely with you to demonstrate not just compliance, but superiority in addressing critical health issues within our targeted specialties. Our trials are designed to provide compelling evidence that speaks volumes to regulators and users alike, setting a solid foundation for market acceptance and success.




The Atlantia Difference

Expert Team

Our team of expert clinical research professionals is well-versed in the ICH-GCP standard and brings a wealth of knowledge in medical, data quality science, and regulatory compliance.

Owned Facilities

We own and operate two cutting-edge clinical facilities, one located in Cork, Ireland, and the other in Chicago, USA. Our facilities feature private consultation rooms, central phlebotomy/PK areas, and specialized equipment such as DXA and bioimpedance machines.

Medical Network

We collaborate with private hospital groups and medical organizations that offer specialized medical supervision and patient referrals for specific patient-focused trials. Whether serving as a CRO, recruitment site, or both, we help you optimize your resources and time effectively.

Hybrid Trials

Strike the perfect balance between rigor and flexibility with our hybrid trial model. Tailored to suit the specific requirements of your study, our trials are crafted to enhance efficiency, speed, and participant involvement while keeping costs in check.


What are clinical investigations?

A clinical investigation of a medical device is a research study which involves human subjects and aims to evaluate the safety or effectiveness of the device for its intended use. Clinical investigations are required for certain types of medical devices before they can be marketed or used in clinical practice.


Clinical validation is the process of demonstrating that a medical device is safe and effective for its intended use and target population.

How do I get an investigation done?

Conducting a clinical investigation for a medical device is a complex process that requires meticulous planning, execution, and adherence to regulatory standards. Working with a Contract Research Organization (CRO) can significantly streamline this process.


A CRO can streamline your medical device's clinical investigation through expert assistance in study design, regulatory guidance, advanced technology recommendations, patient recruitment strategies, budget management, and operational execution. They ensure compliance, efficient recruitment, and data integrity.  Clear communication and defined expectations are key to a successful partnership.

How can Atlantia help?

We use gold standard clinical measurements to validate and verify your data from both quantitative and qualitative clinical outcomes. We can test a host of endpoints from blood, stool, urine, saliva and other outputs. We work with a range of validated tools to assess and quantify patient reported outcomes across a vast array of measurement parameters. Data can be collected directly from patients or through validated tools to report on outcomes.

Our Clinical Investigation Process

Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, obtain a health claim, or as a proof of efficacy.

We work with your chosen notified body to make sure that your trial design meets the regulatory expectations to provide highly compliant study design and clinical program.

Atlantia excels in meeting recruitment milestones with a track record of success. Our access to diverse populations of all ages allows us to efficiently recruit anywhere from 20 to 600 participants per trial, always staying on time and on budget.

Our unique model boosts control, reduces the risk of data discrepancies, and gives our clients peace of mind by centralizing services within one expert organization rather than multiple contract research organizations.

At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.

At Atlantia Clinical Research, our team offers a thorough study reporting service. Our statisticians follow ICH-GCP standards to create a detailed statistical study report, and upon request, we can provide a complete clinical study report as well.

Launch Your
Clinical Investigation

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Trial Design Description of Card here  
Trial Regulation Service Description  
Trial Recruitment Service Description  
Trial Conduct Service Description  
Trial Analysis Service Description  
Trial Reporting Service Description  

Operating Internationally


Chicago, USA

  +1 312 535 9440
   142 E Ontario St #1200, Chicago, IL 60611

Cork, Ireland

+353 21 430 7442
   Heron House, Blackpool Retail Park, Cork T23 R50R