About us
Regulatory Expertise You Can Trust
Three decades of hands-on experience guiding medical device manufacturers through the complexities of global regulatory compliance.
Company Overview
Your Regulatory Partner for EU and Malaysian Markets
Your Regulatory Partner for EU and Malaysian Markets
Your Regulatory Partner for EU and Malaysian Markets
EAP MedTech Consulting Sdn Bhd was founded on a simple premise: medical device manufacturers deserve regulatory expertise that's both world-class and personally accessible. Unlike large consulting firms where you're passed between junior consultants, or sole practitioners without adequate bandwidth, EAP offers the ideal balance—deep expertise from a veteran regulatory professional, backed by the infrastructure of an established Malaysian company. Based in Ipoh, Malaysia, we serve medical device manufacturers worldwide, specializing in the unique intersection of European MDR compliance and Southeast Asian regulatory requirements. Our cross-cultural expertise make us the bridge between Asian innovation and European market access—and vice versa.
Company Snapshot
Your Regulatory Partner for EU and Malaysian Markets
Your Regulatory Partner for EU and Malaysian Markets
ESTABLISHED 2014
(10+ years serving medical device industry)
SPECIALIZATION
EU MDR Compliance & Malaysian MDA Registration
GEOGRAPHIC REACH
Malaysia • European Union • Singapore • Australia
COMPANY TYPE Malaysian Sdn Bhd (Registered Company)
SERVICE MODEL
Direct principal engagement on all projects
DEVICE EXPERTISE
Single-use • Reusable • Active • Implantable • Software
CERTIFICATION
GDPMD certified
Professional Philosophy
"Regulatory compliance isn't about navigating bureaucracy—it's about demonstrating your device's safety and performance in a language that regulators, notified bodies, and market authorities understand. My role is to translate your innovation into regulatory compliance, efficiently and without unnecessary complexity."
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Blok A-3-5 Golf Vista, Lingkaran Meru Valley, 30020 Ipoh, Perak, Malaysia
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