This module is designed to introduce participants with the knowledge on classification of medical devices which are Class A, B, C and D. The process includes the classification of medical device and classification rules for medical devices. Participant will learn on the requirements of classificatio
DurationThis module is designed to introduce participants with the knowledge on classification of medical devices which are Class A, B, C and D. The process includes the classification of medical device and classification rules for medical devices. Participant will learn on the requirements of classification based on manufacturer’s intended purpose for the medical device and a set of classification rules.
These rules will classify medical devices into one of 4 classes of medical devices.
Medical Devices and Technology Centre (MEDiTEC) is officially establish as a research center in Universiti Teknologi Malaysia (UTM) on 12 Februari 2019. With the increasing demand in medical devices and technology, UTM entrusted MEDiTEC to lead in research and development as well as producing local medical devices product in fulfilling the government key focus in health care.
Initiated as Medical Devices & Technology Group (MediTeg) as research group in August 2006 with Prof. Dato’ Ir. Dr. Mohammed Rafiq as a founder. After a decade of excellence, this research group was upgraded to research centre , known as Medical Devices and Technology Centre (MEDiTEC), and lead by Assoc. Prof. Dr. Ardiyansyah Syahrom.
Our area of interest including orthopaedic implant technology, medical informatics, bio-instrumentation and dental implant. Thus, we aimed to be champion in research, development and commercialisation of medical implants and their related technologies. We believe strongly in the value of interdisciplinary pursuits in this challenging field where engineering techniques and technologies from various disciplines are utilised to address needs within the medical industries and healthcare services. We also provide services such as consultation, workshop, testing facilities and provide new smart implant.
Vision
Mission
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