While the past weeks have been quieter on our blog, our work behind the scenes has been as active as ever—supporting medical device companies in planning, managing, and executing clinical investigations. Now that the vacation season is winding down, we’re kicking off the autumn with a closer look at how our CRO services help streamline every step of the clinical investigation process.
Bringing a medical device to market under MDR (EU 2017/745) requires more than an innovative product—it demands a clear, compliant, and well-executed clinical investigation strategy. The early stages of this journey, from planning and documentation to site selection and regulatory approvals, lay the foundation for every success that follows.
At MDS, our Clinical Research Organization (CRO) services are designed to give medical device companies the expertise, resources, and structure they need to navigate this critical phase with confidence.
Strategic Planning: Building the Clinical Investigation Blueprint
A strong Clinical Investigation Plan (CIP) is more than a regulatory formality—it’s the guiding document for your entire trial. This is where study design, objectives, methodology, and analysis strategies come together. In our experience, the most successful investigations start with a CIP that is both scientifically robust and fully aligned with MDR and ISO 14155 standards.
We work closely with you to select appropriate study endpoints, ensure that your protocol meets regulatory expectations, and integrate your business objectives into the clinical design. This approach ensures that your trial generates the right evidence for both compliance and market success.
Documentation: The Backbone of Compliance
In clinical investigations, documentation is not just an administrative step—it’s proof that your study is ethically sound, scientifically valid, and compliant with regulations. Our CRO team supports you in preparing every key document, including the CIP, Investigator’s Brochure (IB), Informed Consent Forms (ICFs), and Case Report Forms (CRFs/eCRFs).
We ensure these documents are accurate, complete, and aligned with regulatory requirements, helping to prevent costly delays during ethics committee or notified body review.
Site Selection and Approvals: Setting the Stage for Reliable Data
Choosing the right clinical sites is critical for patient recruitment, protocol adherence, and data quality. We help you identify and train sites that have the necessary expertise, infrastructure, and access to your target patient population.
From there, we manage submissions to ethics committees and regulatory authorities, ensuring that all required approvals, site permits, and agreements are in place before patient enrollment begins. This proactive approach reduces administrative delays and positions your investigation to start on schedule.
Monitoring for Quality and Compliance
Even at the earliest stage, ongoing oversight is essential. Our Clinical Research Associates (CRAs) provide monitoring tailored to your study’s complexity and risk profile, ensuring that the investigation stays compliant with the CIP, GCP, and MDR requirements.
Through regular site visits, data reviews, and risk-based monitoring, we help maintain data integrity and safeguard patient safety from day one.
What’s next?
Early-phase clinical investigations shape the trajectory of your entire regulatory journey. Next week we’ll cover the journey from first patient to final report and how to keep your study on-track.
With MDS as your CRO partner, you gain the strategic insight, regulatory expertise, and operational support to ensure your trial starts strong and stays on track. To learn more about how our services can support your device compliance, contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
