Ajith John

Global Quality and Accreditation Certification Lead

BSI

About the Speaker

Ajith is a MedTech quality and regulatory leader with extensive experience across global medical device frameworks, including MDSAP, ISO 13485, EU MDR/IVDR, and UK MDR. His background spans clinical engineering, device lifecycle management, multi‑jurisdictional audits, and global QMS leadership, combining hands‑on technical expertise with strategic regulatory insight. At BSI, Ajith supports accreditation and designation for major regulatory schemes through report approvals, competence development, and cross‑regional collaboration. He leads process improvement initiatives that enhance audit quality, manage risk, and optimise operational delivery. A Registered Clinical Technologist, Ajith is passionate about capability building, impactful training, and simplifying complex regulatory expectations to support safe, effective healthcare technologies worldwide.
 

Speaker's Sessions (1)

Session
Insights Stage
Get Ready for Market: A Startup’s Guide to ISO 13485 Compliance
Thursday, Jun 4, 2026
11:30 AM - 12:00 PM | Europe/London
Presentation
English

Get Ready for Market: A Startup’s Guide to ISO 13485 Compliance

This session provides a practical, startup‑oriented guide to building a Quality Management System aligned with ISO 13485 and ready for market access.

You will hear how ISO 13485 supports regulatory requirements, and the expectations during QMS audits. Common audit pitfalls will be highlighted to help startups avoid delays and demonstrate a robust, market‑ready QMS from the outset.
 
Regulation
start-ups
compliance
Speakers (2)
Ajith John
Global Quality and Accreditation Certification Lead, BSI
Michelle Rae
Service Delivery Manager EMEA Medical Devices, BSI
Starts in
1 week
2 days
19hours
19 minutes