Quality Management Advisory and Medical Device Regulatory Support
Assist Malaysian businesses with variant QMS, MDA licensing and registration, GDPMD and audit readiness.
About TRIKA ADVISORY
Our Experience
Trika Advisory offers expert regulatory compliance advisory and practical support for medical device registration to medical-device manufacturers and establishments in Malaysia, covering everything from establishment licensing and product registration to the development of quality management systems and ensuring audit readiness.
Our Approach
Trika Advisory offers expert regulatory compliance advisory and support for medical device registration and quality management systems in Malaysia. We assist manufacturers, local authorized representatives, importers, and distributors with MDA establishment licensing and registration for Class A–D devices, as well as the development and implementation of ISO 13485, GDPMD, and ISO 9001 standards. Our comprehensive support includes document preparation and thorough technical reviews to ensure you have compliant, submission-ready files.
Why Choose Trika Advisory?
Navigating medical device compliance can feel complex, which is why Trika Advisory provides clear and practical support tailored to your needs. With extensive experience in regulatory compliance advisory, regulatory assessments, audits, and quality management systems, we assist manufacturers, local authorised representatives, importers, and distributors in preparing necessary documentation, working towards medical device registration and MDA requirements, and enhancing their quality systems. Let’s simplify your compliance journey together.
SERVICES
QUALITY MANAGEMENT SYSTEM
MEDICAL DEVICE REGISTRATION
QUALITY MANAGEMENT SYSTEM
Develop, implement, and enhance quality management systems in compliance with ISO 13485:2016, GDPMD, and/or ISO 9001:2015, addressing all applicable requirements for medical device registration. Our focused training and regulatory compliance advisory services will help you prepare or improve SOPs, records, controlled documents, and overall process understanding.
ESTABLISHMENT LICENSING
MEDICAL DEVICE REGISTRATION
QUALITY MANAGEMENT SYSTEM
We provide regulatory compliance advisory to help manufacturers, Authorized Representatives (ARs), importers, and distributors obtain establishment licences under Malaysia’s Medical Device Regulations 2012. Our services include assisting with the medical device registration process and navigating the MeDC@St 2.0 online establishment registration application in Malaysia, ensuring adherence to quality management systems.
MEDICAL DEVICE REGISTRATION
MEDICAL DEVICE REGISTRATION
MEDICAL DEVICE REGISTRATION
We provide comprehensive support for medical device registration from Class A to D with Malaysia’s MDA, including classification confirmation, document compilation, and a thorough review of all technical documentation to ensure regulatory compliance with MDA requirements before CAB submission. Additionally, we assist with the MeDC@St 2.0 online establishment registration application in Malaysia, ensuring your quality management systems are aligned with the necessary regulations.
AUDIT SUPPORT
MEDICAL DEVICE REGISTRATION
Prepare for internal, supplier, and external audits and assessments with practical help to strengthen records and audit evidence, ensuring comprehensive support for medical device registration and adherence to quality management systems as well as regulatory compliance advisory.
REGULATORY & COMPLIANCE ADVISORY
Practical guidance on applicable medical device registration, quality management systems, regulatory compliance advisory, and ongoing compliance activities.
Expert Support, Right at Your Door
Looking for an advisor to assist with medical device registration? Trika Advisory offers on-site support for your regulatory compliance advisory and quality management systems needs. On-site visits are available upon request.