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
Mastering Process Validation for Medical Devices: ISO 13485 & Regulatory Requirements Training. Empower your team with the knowledge and skills needed to ensure the reliability and effectiveness of your medical device manufacturing processes through our Process Validation Training.
Benefits of completing iso 13485 medical devices qms lead auditor course successful completion of this irca certified training course by passing the relevant irca examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management system audit.
Medical device quality management system (mdqms) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, and more. Most medical devices will r...
Internal audit is a mandatory requirement of ISO 13485 2016 as it mandates the review and evaluation of the organisation’s quality management system QMS to evaluate its conformity with the ISO 13485 stipulated requirements, compliance with applicable regulatory requirements and whether the proced...
This course is designed to provide participants with the awareness of the ISO 13485:2016 throughout the product life cycle of a medical device, with emphasize on the applicable regulatory requirements. Having completed this course, participants will gain the knowledge of ISO 13485:2016 and aware of
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