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At MMDC Sigma Services, we are committed to helping our clients deliver innovative, compliant, and safe medical solutions. Our expertise spans the Medical Device Act 737, international standards, and the regulatory framework of Act 737. Learn more about our journey, our team, and our commitment to excellence.
We offer a wide range of services to assist companies in maintaining the highest standards of quality and safety. From advising on matters such as medical device registration and GDPMD for license establishment to guiding on the grouping of medical devices, we cover it all. Discover how we can assist you.
Experience & Background
Personally involved in medical device industry on October 2015 until October 2019 as Engineer cum Evaluation Officer at Malaysia Medical Device Authority. Experienced in handling all sort of medical devices known to market and its requirement for registration process based on Medical Device Regulation 2012 (Act 737). Certified and trained on international medical device standards such as ISO 13485, ISO 10993, ISO 14971, and ISO 11137.
Works as freelance consultant for medical device registration and quality management system since October 2019 until MMDC Sigma Services officially established on August 2023. Currently, our company has consult and support ranges of medical device companies, from applying establishment license until product registration application.
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