SURESH
MEDTECH QUALITY LEADERSHIP CONSULTANT
SYNCHRONISE … SYSTEMISE … SUSTAIN
I am Suresh — a systems thinker, people-first leader, and quality transformation expert in the MedTech space. With over two decades of experience, I have spent the last 8 years helping companies align innovation with regulatory excellence across medical devices, software, and AI-enabled healthcare technologies.
I don’t just implement frameworks — I build quality cultures that last.
WHAT I DO
I help MedTech companies, start-ups, and scale-ups navigate the complex world of global regulations and build smart, scalable, and audit-ready systems. Whether you are launching your first SaMD product, preparing for FDA or CE submissions, building an AI framework, or simply trying to untangle your QMS — I can help.
- ISO 13485 | IEC 62304 | FDA 21 CFR Part 820
- ISO 14971 | IVDR / MDR | UKCA
- AI Quality (ISO/IEC 42001-readiness)
- Risk, Cybersecurity & Usability Integration
- Lean Validation | Audit Readiness | Global Submissions
WHY WORK WITH ME
- I simplify complexity — without cutting corners
- I build systems that work for people, not just regulators
- I bring strategic clarity and hands-on execution
- I stay ahead of the curve — especially in AI, digital health, and next-gen regulatory frameworks
And most importantly, I care. About the mission, the patients, and the people building the products.