Our Services - ISO 13485, GDPMD & MDA
Specialized consultancy providing ISO compliance and documentation registration services for medical device manufacturers in Malaysia.
ISO 13485 Quality Management System
GDPMD Compliance (Malaysia)
Medical Device Registration with MDA
The Registration Process
[ 01 ]
Initial Consultation
We begin with a comprehensive audit of your current documentation and compliance landscape to identify gaps and opportunities for optimization.
[ 02 ]
Technical Documentation
We develop and refine your technical files, ensuring they meet the rigorous requirements of ISO 13485 and other relevant medical device standards.
[ 03 ]
Registration & Audit
We handle the formal registration process with certification bodies, providing the necessary evidence and documentation for a successful audit.
Continuous Support
We offer ongoing maintenance and updates to ensure your compliance remains robust and your documentation stays current with regulatory changes.
[ 04 ]
Expertise in Malaysian Regulations
Time & Cost Efficiency
ISO and GPDMD
Specialised MDA Liaison
Start Your Registration
isomedcomconsultant@gmail.com
+60105131143
Office
R1 13D Block J, Jaya One, Jalan Prof Diraja Ungku Aziz, 46200 Petaling Jaya, Selangor.