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Home * Courses * Graduate Diplomas * PE WSQ Graduate Diploma In Medical Technology Manufacturing

Medical Device Technology, or MedTech in short, is emerging as one of the fast-growing industrial sectors worldwide, covering a wide range of applications from medical devices, equipment and apparatus to orthopaedics, diagnostics and medical consumables. In Singapore, MedTech manufacturing has been identified as one of the key pillars driving the manufacturing sectors. As part of Singapore’s growing biomedical sciences sector, the medical technology industry almost tripled its manufacturing output from S$1.5 billion in the year 2000 to about S$4.3 billion in the year 2011. Over the same period, its manpower base more than doubled - from about 4,000 to 9,000. By the year 2015, the medical technology sector is targeting to achieve S$5 billion in manufacturing output. In the next decade alone, the MedTech market is expected to grow rapidly creating huge business opportunities for local companies. As one of the most regulated industrial sectors, it is essential that industrial leaders gain necessary knowledge on MedTech product regulations and skills related to product design, manufacturing processes and management techniques unique to this niche sector. The MedTech market is expected to grow rapidly creating huge business opportunities for local companies as a result of localization needs of MNCs.

The PE WSQ Graduate Diploma in MedTech Manufacturing is a training programme developed by the Singapore Institute of Manufacturing Technology (SIMTech) and the SkillsFuture Singapore (SSG) Agency. The programme is designed to provide the manufacturing practitioners, industry engineers and managers with essential knowledge and skills on MedTech regulatory requirements, product design and innovation, manufacturing processes and validation, quality control systems as well as manufacturing management systems. This programme will be conducted through a series of lectures, hands-on exercises and case studies by experienced industry specialists and SIMTech researchers.

Why This Course

This programme aims to equip personnel in the PE industry with cutting-edge technologies and skills to achieve high-value manufacturing and greater productivity. Since the inception of this programme in 2010, the programme has trained over 400 professionals, managers, engineers, and technicians (PMETs) with their companies benefitting from participating in the course.

Who Should Attend

This course especially caters to industrial engineers, supervisors, managers, researchers and technical staff in the MedTech industry.
  


Participants will be awarded the Graduate Diploma after successfully completing five modules. Alternatively, participants will be awarded a WSQ Statement of Attainment electronic certificate (e-Cert) for passing any individual module of their choice. Visit here for more information about the e-Cert.


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(Training Hours: 45 hours)
CRS-Q-0027974-PE
Click here to visit the SSG Course Directory for this module.

Course Introduction

Knowledge of regulatory requirements plays a critical role in ensuring compliance with the various laws and regulations guiding the development and commercialisation of health care products. As medical technology and bioscience companies mature, their need for trained regulatory personnel intensifies.


Developed and taught by experienced personnel from the certification industry, this module aims to provide students with a broad regulatory foundation that incorporates exposure to the practical, real-world applications of the regulations and an appreciation of the important role played by regulatory affairs professionals in the medical technology industry. Throughout the course, the instructors will engage students with the use of relevant case studies and hands-on exercises. This module offers students an opportunity to appreciate and understand the subjective and interpretive aspects of the regulations, thereby fostering in them the ability to critically analyse the interaction between the regulatory and development processes.

Topics Include

  • US medical device regulations: FDA 21 CFR 820.30 and 501K
  • European medical device regulations: CE and ISO
  • Current good manufacturing practices (cGMP), good clinical practices (GCPs), good laboratory  practices (GLPs)
  • Medical device regulations practiced in Japan, Canada, and Australia; GTHF movement
  • Medical device vigilance, post-market surveillance (PMS), and risk management
  • Preparing for certification auditing

(Training Hours: 39 hours)
CRS-Q-0027978-PE
Click here to visit the SSG Course Directory for this module.

Course Introduction


This unit provides comprehensive and up-to-date knowledge of regulatory and quality issues associated with this highly regulated industry. Students will learn about the different regulatory expectations and best practices regarding sterilisation, labelling requirements, and auditing. In addition, the general requirements of a vendor/supplier (outsourcing) control program, which include a process for selection, audit, approval, and qualification based on the material/equipment/service being delivered, will also be addressed. Also addressed in the module are the various effective methods for corrective and preventive action systems that ensure the quick resolution of costly quality issues. The use of computer systems and solutions to better manage and address risk areas will also be discussed.


At end of the module, students will learn how to review their current, or proposed, manufacturing systems/processes for regulatory and quality vulnerabilities and to develop an action plan intended to close those gaps. Overall, this would help them improve their compliance position and manufacturing efficiency.

Topics Include

  • Traceability and labelling; labelling controls in the medical device industry
  • Sterilisation for medical devices packaging; packaging waste
  • Auditing and qualifying suppliers and vendors
  • Corrective and preventive action
  • Automating the production quality and traceability system

(Training Hours: 43 hours)
CRS-Q-0027977-PE
Click here to visit the SSG Course Directory for this module.

Course Introduction

This module will cover the basic manufacturing processes involved in the fabrication of biomedical products, which include precision forming, the machining and joining of metals, plastics and ceramic materials, as well as surface cleaning and coating technologies. The module will be taught through classroom lectures on process fundamentals and methodologies, as well as through lab demonstrations. Economical mass production-related issues will be emphasised in this module.

Topics Include

  • Introduction of MedTech materials and manufacturing processes
  • Metal forming processes
  • Injection moulding technologies
  • Machining technologies for MedTech materials
  • Laser processing for MedTech materials and applications
  • Surface cleaning and modification
  • Surface coating technologies
  • Laser-based joining
  • Adhesive bonding

(Training Hours: 36 hours)
CRS-Q-0027976-PE 
Click here to visit the SSG Course Directory for this module.

Course Introduction

This module provides students with practical training on effective manufacturing, inventory control, and the analyses, optimisation, and management of the various supply chain operations. This course will be conducted through a series of lectures, software tool demonstrations, pertinent case-study analyses, and hands-on model building exercises for selected industrial applications. Specifically, it will provide students with the knowledge, skills, and practical analytic methods for improving their efficiency across the manufacturing and supply chain processes of their respective organizations. It will also assist them in streamlining or optimising their operations and role management, while maximising customer satisfaction.


Topics Include

  • Overview of manufacturing and supply chain management
  • Supply chain and inventory optimization and distribution
  • Production planning and optimisation
  • Manufacturing execution system
  • Asset tracking: Machine utilisation and job order tracking
  • Machine health monitoring
  • Case studies

(Training Hours: 48 hours)
CRS-Q-0027975-PE

Click here to visit the SSG Course Directory for this module.

Course Introduction


Through an interactive instruction format, this course will cover the general context for inventing new MedTech devices and instrumentation, including the study of various methods for validating medical needs, techniques for analysing intellectual properties, the basics of regulatory and reimbursement planning, brainstorming, and early prototyping. Upon completion of this course, participants will have an understanding of the framework for design control to meet industry and client requirements. Additional topics, such as manufacturing transfer systems and general quality systems that are related to the design process, will also be covered. Emphasis will be placed not only on the regulatory aspects but also on effective design strategy, which is critical in order to avoid wastage of time and money. Exercises will be completed by students to reinforce their understanding of the key concepts.

Topics Include

  • Medical device classification
  • Design control file and design history file
  • Human factors in design
  • Basic prototyping
  • Techniques of intellectual property analyses and feasibility
  • Design validation and verification
  • Risk analysis for design control

 

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  • Applicants should possess a degree in any discipline or a diploma with a minimum of 3 years of related working experience.
  • Proficiency in written and spoken English.
     

The full course fee for a complete Graduate Diploma is S$15,000 before course fee funding and GST.
The fee for each individual module is S$3,000 before course fee funding and GST.

Please note that fees and funding amount are subject to change.

Course Fee Funding

All Singapore Citizens and Permanent Residents aged ≥ 21 years

Singapore Citizens


Up to 50% of course fee (capped at $15/training hour)

SME Sponsored³

Aged ≥ 40 years1

Aged ≥ 35 years and earning ≤ $2,000/month2

Up to 90% of course fee
(capped at $50/training hour)

95% of course fees

  • All Singaporeans and Permanent Residents aged 21 years and above can enjoy course fee funding of up to 50% of the course fee (capped at S$15/training hour).

  • ³ Singaporean or Permanent Resident employees fully sponsored by SMEs can enjoy course fee funding support of up to 90% of the course fee (capped at S$50/training hour) under the Enhanced Training Support for Small & Medium Enterprises (SMEs) scheme,  subject to eligibility criteria.

  • 1 Singaporeans aged 40 years and above can enjoy course fee funding of up to 90% of the course fee (capped at S$50/training hour) under the SkillsFuture Mid-career Enhanced Subsidy.

  • 2 Singaporeans aged 35 years and above with earnings not more than S$2,000 per month can enjoy course fee funding for 95% of the course fee under the Workfare Training Support (WTS) scheme.

  •  Singaporeans aged 25 years old and above are eligible for SkillsFuture Credit which can be used to offset course fees.

*Note: The course participants must also meet the following criteria to qualify for the course fee funding:

  • Achieve at least 75% course attendance; and
  • Take all assessments.

 

Singapore Institute of Manufacturing Technology
2 Fusionopolis Way, Innovis Level 8
Singapore 138634

How to Reach SIMTech@Fusionopolis Two
Visitor Parking at Fusionopolis Two

View the course schedules  here.

(Click on the respective Commencement Dates to view the course schedules.)
(Click on the respective Registration Closing Dates to submit your registration online.)
 

Note: Brochures are not available for those in italics.

  • Main Brochure | Graduate Diploma in Medical Technology Manufacturing
  • Module 1 | MedTech Regulatory Requirements (45 hours)
  • Module 2 | MedTech Manufacturing and Quality System (39 hours)
  • Module 3 | MedTech Manufacturing Processes (43 hours)
  • Module 4 | MedTech Manufacturing and Supply Chain Management (36 hours)
  • Module 5 | MedTech Device Design Innovation and Development (48 hours)
 


  

 
 
 
 
 
         

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