Achieving EU MDR Compliance at Scale
How Caristo Diagnostics Maintain Clinical Evaluation Excellence Without Growing Headcount
Project Type: Clinical Evaluation Document Suite, Ongoing Literature Monitoring and SotA Updates
Introduction
Caristo Diagnostics, an innovator in AI-driven cardiovascular diagnostics, faced a common challenge: meeting the stringent clinical evidence requirements of the EU Medical Device Regulation (MDR) without expanding its internal team. Instead of hiring in-house regulatory staff, Caristo partnered with SciMed to develop and maintain its Clinical Evaluation Report (CER). Over five years, this long-term collaboration enabled cost-effective, audit-ready compliance and supported seamless growth into the EU market.
Key Takeaways: How SciMed Helped Caristo Maintain MDR Compliance Efficiently
All CERs accepted without major notified body comments, validating the robustness of SciMed’s Clinical Evaluation approach.
Sustained EU MDR compliance since 2019 through scheduled CER updates and continuous literature monitoring.
No need to hire internal regulatory staff, reducing cost and retention risks for a growing medtech business.
Faster response times and consistent support, thanks to a dedicated, small-team delivery model.
Improved operational efficiency, with zero duplication or rework across multiple CER cycles.
The Challenge: Scaling Regulatory Compliance Without Internal Headcount
Caristo needed to prepare a Clinical Evaluation Report (CER) to support CE marking for its AI-powered diagnostic solution under the EU MDR. As an early-stage company:
It lacked a full in-house regulatory team.
Resources were limited, and timelines were tight.
Hiring posed risks—specialist talent is expensive, difficult to retain, and time-consuming to onboard.
The business needed a long-term solution that would ensure regulatory quality and consistency without the overhead of full-time staff.
Need to scale MDR compliance without expanding your team?
The Solution: Ongoing Clinical Evaluation Support with SciMed’s Document Suite
To address these challenges, Caristo partnered with SciMed, leveraging our:
Clinical Evaluation Document Suite: Including initial CER development (2019) and scheduled updates in line with EU MDR Article 61 and Annex XIV requirements.
Ongoing Literature Monitoring and State-of-the-Art (SotA) Updates: Ensuring the CER remains current with evolving scientific, clinical, and regulatory expectations.
Dedicated Regulatory Team: A stable group of SciMed analysts familiar with Caristo’s technology, enabling continuity and deep product knowledge.
Flexible, On-Demand Support: SciMed’s experts remained available for rapid query resolution and strategic regulatory advice.
This model allowed Caristo to meet MDR expectations efficiently while preserving internal focus on innovation and growth.
The Results: Seamless EU MDR Compliance Since 2019
The SciMed–Caristo collaboration has resulted in:
Zero major comments from notified bodies across multiple CER submissions and renewals.
More than five years of consistent compliance—with scheduled updates delivered efficiently and on time.
Avoidance of costly in-house regulatory roles, saving both money and long-term retention effort.
Trusted regulatory partnership that scales alongside Caristo’s business without introducing complexity or rework.
Caristo’s clinical/regulatory function is now a model of streamlined outsourcing, enabling growth while maintaining audit-ready clinical documentation.
Conclusion: Why Clinical Evaluation Partnerships Work for Scaling MedTech Innovators
Caristo’s success story illustrates the value of outsourcing clinical evaluation tasks to a specialised partner like SciMed. For MedTech companies developing innovative devices, SciMed’s Clinical Evaluation Document Suite and Ongoing Literature Monitoring provide a proven, scalable path to EU MDR compliance. The partnership allowed Caristo to maintain high standards in clinical documentation; without the cost, risk, or delay of building internal capability.
