PROFESSIONAL COURSES

MODULE

Introduction to Medical Device Technology and Regulatory Requirements

This course is designed to introduce medical device technology and regulatory systems. This course also lets the student implement and demonstrate a medical device technology and regulatory system with some basic knowledge of planning, design and development, verification and validation of a medical device. Some medical device classes will be discussed in this course and regulatory assessment.

QMS for Medical Device Regulatory Compliances

 This course is to provide in-depth understanding on Quality Management System for medical device for those involved in the development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

This course aims to help participants in understanding the scope and use of ISO 13485:2016 in complying with the Medical Device Regulations.

Medical Device Classification

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 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.

Conformity Assessment

This module is designed to introduce participants to procedures on assessing conformity on medical devices towards verifying compliance to the four elements of the conformity assessment which are, Quality management system (QMS), Post-market surveillance (PMS) system, Summary technical documentation (CSDT) and Declaration of conformity (DoC). The process includes understanding the Full Conformity Assessment procedure and Conformity Assessment by Way of Verification.

Good Distribution Practice for Medical Device and MS2058

GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737). GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It shall be used by both the internal and external parties to determine the ability of an establishment to meet the requirements specified within.

Part of GDPMD Requirements in Code of Practice for good engineering maintenance of active medical devices (MS2058). This Code of Practice is applicable to the active medical devices placed for use in any healthcare facility or any other facility which requires maintenance.

Post Market Surveillance and Vigilance

This module is designed to introduce participants to the concepts of medical device post market surveillance and vigilance, and to understand the process of effective post market and surveillance. The process includes understanding the quality management system’s post market requirements, medical device complaint and problem understanding, mandatory problem reporting requirements and medical device field corrective action activities.

Biocompatibility

The content of this course provides an overview and, critical evaluation to the most relevant aspects related to the biocompatibility between biological tissues and invasive materials. The biocompatibility test of medical device is a mandatory part of the conformity assessment. The goal is to enable students to acquire the knowledge that assist them to understand all the approaches and multidisciplinary aspects, especially those related with materials engineering, involved in the reaction of biological systems to biomaterials. The purpose extends to the development of practical skills through experimental classes.

Artificial Intelligence

This module is designed to introduce participants to the fundamentals of artificial intelligence (AI). It discusses the theoretical and practical aspects of several approaches in AI. Approaches which emphasize on machine learning such decision trees, regression, artificial neural network and clustering will be discovered in this course. Furthermore, the courses also introduce the participants with recent deep learning approach such as Convolutional Neural Network and how to implement this approach in solving real problem. Participants will be given problem sets and hands-on simulation in developing a model of cognitive system to effectively solve real world problems.

Auditing Techniques

This module is designed to guide participants through the entire audit process, from initiating the audit through to conducting audit follow-up in compliances with principles and practices of effective quality management system audits against ISO 13485, in accordance with ISO 19011, “Guidelines for auditing management systems” and ISO 17021, as applicable. This includes process of auditing, audit preparation activities, investigating to collect evidence of the audit, requirement of QMS certification, regulatory compliance to the Authority, and analysing or reporting of the audit.

Introduction to Anatomy and Physiology

This course is studying the anatomical terminology, body’s structures orientation and physiological event of human body systems. This course includes the study of several body systems. The gross anatomical features of the body systems are presented with relevant emphasis on the structural and functional interrelationships. In conjunction with classroom instructions, the anatomy and physiology tutorial component requires students to apply knowledge from the classroom to laboratory models, experiments and critical thinking application exercises. The content of the lectures is adapted to engineers; an emphasis is placed on medical terminology as a very important language for the technician or researcher involved in biotechnology, biomedical investigations, or clinical research. This course does not fulfil requirements for medical and dental schools. However, it is still applicable for many biomedical disciplines such as research and technology developments, medical technology consultancy, and health care industries.

Software as Medical Device

This course focuses on the process of developing software as medical devices (SaMD). This includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with Software of Unknown Provenance (SOUP)/ Off-The-Shelf (OTS) software.

The course covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1, IEC80001-1, IEC80002-3.

The course is suitable for anyone working with software development, such as R&D engineers, quality assurance department and auditors of software development. The course does not cover actual coding.

Good Submission Practice

This module is designed to introduce participants on the elements of good medical device registration submission. The objective of this course is to help applicants prepare a good quality submission leading to successful registration. The ‘principles’ of a good submission describe the key elements of Good Submission Practice which applicants should follow in order to achieve successful product registration.

Combination products (Medical Device and Drug)

This module is designed to introduce participants with the knowledge on registration and requirements of process of drug-medical device/ medical device-drug combination products and change/variation application. Drug-medical device/ medical device-drug combination products are regulated according to the classification whether as drug or medical device based on the primary mode of action (PMOA).

Combination products regulated as drug by Drug Control Authority is in accordance with the requirements set forth in the Control of Drugs and Cosmetics Regulations 1984 which is promulgated under Sale of Drug Act 1952 and any other relevant documents published by NPRA. Combination products regulated as medical device by Medical Device Authority is in accordance with the requirements set forth in the Medical Device Act 2012 (Act 737) and its subsidiary legislations, and any other relevant documents published by MDA.

Medical Gas System and Fluid Dynamics

This module is designed to introduce participants to the concepts and methods of engineering design process in medical gas system with control by related ISO standards, creatively and effectively. The process briefly includes quality system, design control, problem understanding, concept generation, concept selection, design verification and design validity.

Medical Device Labeling and Code of Advertisement

 This module is designed to introduce participants on the significance and requirements of labelling and the Code of Advertisement for medical devices, and to facilitate compliance of the two regulatory elements.

14 + 4 =

Research Ecosystem
Universiti Teknologi Malaysia UTM Nexus - Research & Innovation

Office of Deputy Vice Chancellor (Research & Innovation)

DVCRI Profile Johor Bahru Office Kuala Lumpur Office

Higher Institution Centre of Excellence (HI-COE)

Advance Membrane Technology Research Centre - AMTEC Institute of Noise & Vibration - INV Wireless Communication Centre - WCC

Research Institute

Centre of Excellence (COE)

Institute of High Voltage & High Current - IVAT UTM-MPRC Institue for Oil & Gas - IFOG Centre for Artificial Intelligence & Robotics - CAIRO Centre for Engineering Education - CEE Centre for Advanced Composite Materials - CACM Innovation Centre in Agritechnology for Advanced Bioprocessing - ICA Institute of Bioproduct Development - IBD

Service Entity

Research Management Centre - RMC Penerbit UTM Press Centre for Community & Industry Network - CCIN Innovation & Commercialisation Centre - ICC University Laboratory Management Centre - PPMU Institut Sultan Iskandar - UTM-ISI

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