Category Archives: 2026 Training

EU Medical Device Regulation (EU MDR 2017/745)

DATE: 5 & 6 August 2026 (Wed & Thu)

TIME: 9.00am – 5.15pm

TRAINING MODE: Online (via Zoom)

INTRODUCTION
The EU Medical Device Regulation (MDR) 2017/745, published on 5 May 2017, introduced a comprehensive framework for regulating medical devices within the European Union. This regulation replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC), marking a significant shift toward more stringent and harmonized requirements.

This updated regulation outlines detailed requirements for economic operators — including manufacturers, authorized representatives, importers, and distributors — as well as for notified bodies. In addition to reinforcing existing rules, the EU MDR introduces new and updated classification criteria for medical devices, reflecting the evolving landscape of healthcare and medical technology, and patient safety.

This course will guide participants through the intricacies of the MDR, ensuring they are equipped with the knowledge to navigate the regulatory landscape effectively.

COURSE OBJECTIVES
After participating in the training, you will be able to understand:

• The structure of the EU Medical Device Regulation (EU MDR).
• The general obligations of economic operators.
• The importance of appointing a Person Responsible for Regulatory Compliance, and who can be appointed to the role.
• The additional rules in the EU MDR for medical devices classifications.
• The requirements for risk management process and Technical Documentation (Annex II and III of the EU MDR).
• The requirements for clinical investigation and evaluation.
• The different assessment route in accordance with Article 52.

COURSE OUTLINES
1. Background of the EU Medical Device Regulation and its structure
2. The role and responsibilities of the economic operators
3. Person Responsible for Regulatory Compliance
4. Medical device classification rules
5. Risk management and Technical Documentation
6. Clinical investigation and evaluation
7. Conformity assessment procedures

ISO 13485:2016 Quality Management System

DATE: 3 & 4 August 2026 (Mon & Tue) 

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

INTRODUCTION
ISO 13485:2016 is the internationally recognized Quality Management System (QMS) standard specifically developed for organizations involved in the design, manufacture, installation, and servicing of medical devices. It places strong emphasis on regulatory compliance, risk-based thinking, process control, and continual improvement to ensure the safety, performance, and reliability of medical devices throughout their lifecycle.

This training provides participants with a practical and structured understanding of ISO 13485:2016 requirements, focusing on how the standard is applied in real manufacturing and quality system environments. The course bridges the gap between standard requirements and day-to-day operations, helping organizations establish, implement, maintain, and improve an effective medical device QMS.

Through interactive discussions, real-life examples, and industry best practices, participants will gain clarity on key QMS elements such as management responsibility, resource management, risk management, product realization, supplier control, documentation, internal audit, CAPA, and regulatory alignment. The training is designed to support organizations in achieving compliance with global regulatory expectations, and improving operational effectiveness.

COURSE OBJECTIVES
After participating in the training, you will be able to:

• Understand the key requirements and intent of ISO 13485:2016.
• Recognize how ISO 13485 applies to daily work activities in the medical device industry.
• Understand and interpret the ISO 13485:2016 requirements.
• Learn the practical implementation examples.

COURSE OUTLINE
1. Introduction of ISO 13485:2016
2. 7 Quality Management Principles
3. Clause by clause interpretation of ISO 13485:2016

• Clause 0: Introduction
• Clause 1: Scope
• Clause 2: Normative References
• Clause 3: Terms and Definitions
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement

Effective Root Cause Analysis

DATE: 29 July 2026 (Wed)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

INTRODUCTION
Root Cause Analysis (RCA) is one of the most common actions required at every organisation, not only to solve day-to-day operational problems but also to play an important role in other improvement activities such as lean sigma, risk management, etc. Root cause analysis involves searching backwards from an undesirable effect (or problem) to its cause(s) and addressing those causes to effectively prevent recurrence.

This training provides the learner with a basic understanding of the principles and techniques of effective root cause analysis and providing concepts needed to effectively perform investigation.

COURSE OBJECTIVES
After participating in the training, you will be able to:

• Understand the principles and techniques of effective root cause analysis.
• Recognise common barriers to root cause analysis and apply techniques to overcome those barriers.
  

COURSE OUTLINE
1. Challenges in root cause analysis
2. Benefits of effective root cause analysis
3. Symptoms vs cause of the problem
4. Contributing factor vs root cause
5. Types of root cause
6. Root cause analysis problem solving model
7. Root cause analysis tools
8. Actions to prevent future problem – corrective action preventive action
9. Human error
10. Root cause analysis in a regulated environment
11. Tips for performing effective root cause analysis