Building the talent pipeline in the medical device industry.
Your No.1 Medical Device Training Provider
Appointed Secretariat and Authorised Training Provider for the Association of Malaysian Medical Industries (AMMI).
Upcoming Medical Device Training Courses
5-6 March 2024: Cleanroom and Associate Controlled Environment
Participants will be introduced to the principles and methodology of air cleanliness classification in cleanrooms, the prerequisite and optional tests, changing room best practices with reference to the standard, implementation of the standard’s specified requirements during operation and an understanding of biocontamination, principals for its control and monitoring.\
13-14 March 2024: Medical Device Identification, Classification and Labelling
This course aims to provide participants with the necessary knowledge on what is a medical device as defined by regulators and the standards, classify the device correctly as stipulated by the appropriate regulation
19 March 2024: Cost of Quality
This course is designed for all functions and levels of QA organization who need to gain understanding on cost of quality, especially those who are new to quality function.
27 March 2024: Data Integrity ALCOA
This course aims to impart knowledge on the background development of data integrity principles, related requirements within the ISO 13485 2016, consolidated principles of data integrity as of 2023 from the regulators with interpretation, explanation and potential risk associated in event of non-compliance with each of these principles.
2 April 2024: Effective Root Cause Analysis
This training provides the learner with a basic understanding of the principles and techniques of effective Root Cause Analysis and provided concepts needed to effectively perform investigations.
17-18 April 2024: ISO13485:2016 Quality Management System
Participants will be introduced to the concepts required to understand, implement and maintain an ISO 13485 2016 medical device quality management system (QMS) and knowledge on the utilisation of mandatory requirements within an ISO 13485 2016 compliant QMS for the one or more stages of a medical device life-cycle.
22-23 April 2024: Risk Management for Medical Devices
This training aims to provide participants with a clear understanding and insight into the new EN ISO 14971:2019+A11:2021 requirements.
24-25 April 2024: ISO13485:2016 Internal Audit
This training is designed for participants who are new and also those seeking to enhance their auditing skill as it intends to produce a pool of internal auditors with the necessary skill and knowledge to conduct effective internal audits.
7-8 May 2024: NCR/CAPA/ Complaint Handling
This course introduces the concepts needed to understand the requirements of NCR, CAPA & Complaint Handling under ISO 13485:2016 QMS and US FDA Quality System Regulation (21 CFR Part 820). It also provides guidance on how to effectively address each of it with step-by-step process and root cause analysis with problem-solving tools.
14 May 2024: 6S for Visual Workplace
This course provides a comprehensive understanding of 6S principles. Upon completing this course, delegates will possess an advanced understanding of 6S principles, enabling them to create safer work environments while optimising processes.
Looking to gain valuable exposure in the Medical Device Industry?
Our internship programme offers hands-on experience in medical device training, association management and event management . You’ll have the opportunity to gain valuable insights that will prepare you for success in your future career. Don’t miss out on this opportunity to take your skills to the next level – apply now!
Submit your resume to email@example.com
Your No 1 Medical Device Training Provider for Every Step of Your MedTech Journey
Quality * Regulatory * Manufacturing Excellence * Technical Competency
* New Graduates/ Apprenticeship * Reskilling