“Zaritech Dynamics operates with a core commitment to international safety and quality standards. Our engineering workflow is built on the principle that a medical device is only as good as its compliance with rigorous regulatory frameworks.”
International Standards
ISO 13485 Compliance: Deep understanding of Quality Management Systems (QMS) specifically for medical devices.
ISO 14971 Risk Management: Application of risk analysis, evaluation, and control throughout the product lifecycle.
Malaysian Regulatory Framework
Medical Device Act 737: Expert knowledge of the Malaysian regulatory landscape and registration requirements.
GDPMD: Familiarity with Good Distribution Practice for Medical Devices in the Malaysian market.
Device Classification Expertise
Classification Analysis: Technical proficiency in classifying medical devices (Class A, B, C, D) based on risk—specifically for active devices like pacemakers and Holter monitors.