Bioexcelife
Dear Innovator,
Are you preparing your medical device for EU MDR compliance? The Clinical Development Plan (CDP) is more than just a regulatory formality—it’s your blueprint for generating meaningful clinical evidence.
At Bioexcel, we help you draft and execute MDR-aligned CDPs that accelerate your path from first-in-human trials to post-market follow-up.
What’s Inside a Strong Clinical Development Plan?
✅ General Purpose & Intended Use
Clearly define your device’s purpose, users, and value proposition.
✅ Exploratory Investigations
Plan early feasibility and pilot studies to refine protocols.
✅ Confirmatory Trials
Design robust, multicenter pivotal studies to demonstrate safety and effectiveness.
✅ Post-Market Clinical Follow-Up (PMCF)
Ensure long-term safety and performance through real-world data.
✅ Milestones & Data Analysis
Timely execution and statistical validation across all phases.
Why Is the CDP Critical?
- It aligns with Annex XIV of EU MDR 2017/745
- It integrates ISO 14155:2020 standards
- It supports CE marking and Notified Body submissions
- It builds confidence among regulators and clinicians
How Bioexcel Supports You
End-to-end CDP development
Protocol drafting & study design
PMCF strategy & real-world evidence planning
Submission-ready documentation & data analysis
Experience across IVDs, implants, SaMD, and AI-based diagnostics
Ready to Plan Your Clinical Journey?
Let’s design your CDP and position your product for a successful MDR submission.
📧 Contact: bd@bioexcelife.com
