About Us
About MedTech Compliance
Who We Are
MedTech Compliance was created to support innovators who are building safe, effective and meaningful medical technologies, but need clear, practical guidance through MDR requirements, ISO 14971 risk expectations and clinical evidence obligations. Our focus is simple: to make compliance approachable, structured and achievable for teams of all sizes. We specialise in helping startups, SMEs and developing manufacturers build documentation that is not only compliant, but genuinely clear, consistent and ready for audit or review.
About Me
Marco Cocorocchio, PhD
I founded MedTech Compliance to help teams bring safe and meaningful technologies to market without being overwhelmed by MDR requirements. Over the years, I realised that many startups and smaller manufacturers struggle not because they lack expertise, but because compliance feels unclear, heavy, and disconnected from their daily work. I wanted to change that.
My core background is in clinical evaluation, where I’ve authored numerous CERs, guided literature appraisal, benefit–risk assessments, and supported teams through the entire clinical evidence process. I’ve also gained extensive experience in MDR remediation, successfully helping teams close findings across CERs, PMCF and risk documentation.
Alongside clinical work, I’ve contributed to risk management improvements, including risk file remediation, hazard analysis, complaint‑based risk assessments, and risk database optimisation. I also support teams with PMCF activities, from planning to reports.
I now use this combined experience to help MedTech teams build documentation that is clear, structured and genuinely useful, not something created just to “tick a box.” My approach is collaborative, practical and focused on giving you confidence in your regulatory journey.
I’m here to help you move forward with clarity and a strong compliance foundation.
Who We Support
MedTech Compliance works with:
- Startups building their first CERs, risk files or PMCF documentation
- SMEs updating technical files or undergoing MDR remediation
- Growing manufacturers improving documentation quality or preparing for audits
- Founders needing clarity, templates, structure or early strategic direction
Whether you’re preparing for CE marking, addressing Notified Body feedback, or strengthening your internal processes, we can help you move forward confidently.
Our Mission
To empower MedTech teams with the clarity and structure they need to bring safe, compliant technologies to market, without confusion, overwhelm or unnecessary complexity.
Clear documentation, informed decisions, better outcomes.
Ready to Work Together?
If you’re looking for structured, practical support across risk, clinical or MDR documentation, let’s discuss your device and plans.