Ensure quality at the heart of your operations
For over 30 years, TÜV SÜD has provided market access solutions and expert partnership for medical device manufacturers and suppliers. We know your challenges and concerns. Our dedicated team of over 400 medical experts, engineers, and doctors, positioned all over the globe, provide assessments that cover the full life cycle of your medical device. Our team of local experts within your local markets is the largest of its kind. Choose certainty and add value with TÜV SÜD.
TÜV SÜD Malaysia is a Conformity Assessment Body (CAB) recognized by Ministry of Health Malaysia to carry out GDPMD, ISO13485 audits and product approval review under Medical Device Act 2012 (Act 737).
To know more about regulatory framework for medical devices in Malaysia, click here.
ISO 13485 Quality Management System
ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
To know more about this standard, click here.