When you work with ClinicalMe, you engage a consulting partner with:

• Over 10 years of combined experience in clinical and performance evaluation and global clinical research

• Proven expertise supporting EU MDR and IVDR submissions across multiple therapeutic areas

• Experience engaging with Notified Bodies and Competent Authorities

• Knowledge spanning pre-market, post-market, and lifecycle clinical activities for medical devices and IVDs

• A practical ability to translate complex regulatory and clinical requirements into clear, defensible documentation systems

ClinicalMe values long-term partnerships built on rigor, transparency, and trust. We work closely with clinical, regulatory, and quality teams to deliver thoughtful solutions that support sustainable compliance and confident decision-making.

We look forward to connecting and exploring how we can support your clinical and regulatory objectives.