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Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021)

DATE: 18 & 19 May 2026

TIME: 9.00am – 5.15pm

VENUE: Dorsett Grand Subang Hotel, Selangor

DURATION: 2 full-day course

INTRODUCTION
Risk management plays a pivotal role in ensuring the safety and effectiveness of medical devices,
safeguarding patient health, and meeting regulatory requirements. With the increasing complexity of
medical technologies and global regulatory expectations, manufacturers must adopt robust risk
management practices to identify, analyze, evaluate, and mitigate risks throughout the product
lifecycle.

This comprehensive training program focuses on ISO 14971:2019 / EN ISO 14971:2019/A11:2021, the
globally recognized standards for medical device risk management. These standards outline a
systematic approach to managing risks, integrating safety considerations into the design, production,
and post-market phases of medical devices.

Key Features:

• Comprehensive coverage: In-depth understanding of ISO 14971:2019 and EN ISO
  14971:2019/A11:2021 requirements.
• Regulatory alignment: Guidance on integrating risk management into quality management systems
  and meeting regulatory expectations.
• Expert instruction: Delivered by experienced professionals with extensive knowledge of medicaldevice regulations and standards.

Take the first step toward strengthening your risk management expertise and ensuring compliance
with global standards. Join us in mastering risk management for medical devices to enhance patient
safety and product reliability!

COURSE OBJECTIVES
This training aims to provide participants with a clear understanding and insight into the EN ISO
14971:2019/A11:2021 requirements. The training takes a look at the major changes in the 2019
update/revision and also covers some of the commonly used risk management tools such as FMEA,
FTA, etc.

COURSE OUTLINE
1. Introduction
2. Understanding basic principles of risk management

• Standards & regulation
• What is risk management
• The importance of risk management
• When to initiate risk management
• Use of risk management

3. EN ISO 14971:2019/A11:2021 requirements

• Clause 1 Scope
• Clause 2 Normative Reference
• Clause 3 Terms and Definitions
• Clause 4 General Requirements for Risk Management System
• Clause 4.1 Risk Management Process
• Clause 4.2 Management Responsibilities
• Clause 4.3 Competence of Personnel
• Clause 4.4 Risk Management Plan
• Clause 4.5 Risk Management File
• Clause 5 Risk Analysis
• Clause 6 Risk Evaluation
• Clause 7 Risk Control
• Clause 8 Evaluation of Overall Residue Risk
• Clause 9 Risk Management Review
• Clause 10 Production and Post-Production Activities

4. EN ISO 14971:2019 background
5. EN ISO 14971:2019 vs EN ISO 14971:2012 vs EN ISO 14971:2009 vs ISO 14971:2007
6. Differences in the structure and content of ISO 14971:2007 vs ISO 14971:2019
7. Review on EN ISO 14971:2019/A11:2021 Annex Z
8. Highlighted changes in EN ISO 14971:2019 vs EN ISO 14971:2012
9. Changes in ISO / TR 24971:2020
10. Summary of what need to be done to meet EN ISO 14971:2019/A11:2021 requirements
11. Extra information

ISO 13485:2016 Quality Management System

DATE: 11 & 12 May 2026

TIME: 9.00am – 5.15pm

VENUE: Dorsett Grand Subang Hotel, Selangor

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

Acceptance Sampling Method

DATE: 6 May 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 1 full-day course

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

• The concept of Sampling Plan.
• Advantages & disadvantages of sampling.
• Types of Acceptance Sampling Plan.
• How to use Sampling Plan graphs and tables.
• The relationship between Acceptable Quality Level (AQL) and Operating Characteristic (OC) Curve.
• Overview of Acceptance Sampling Plan for Attribute ANSI Z1.4/ ISO 2859-1.
• The condition when applying Switching Rules and Acceptance Sampling Procedures.
• The uses of Single Sampling Plans for Critical, Major and Minor Nonconformances.
• The use of Lot Formation and Random Sampling.
• The use of Tightened and C=0 Sampling Plans, Multiple Defects Per Unit Sampling Plans, Double Sampling Plans, and Isolated Lot Sampling Plans.

COURSE OUTLINE
1. Sampling plan concept
2. Advantages and disadvantages of sampling
3. Types of Acceptance Sampling Plan
4. Sampling plan graphs

ISO 13485:2016 Internal Audit

DATE: 28 & 29 April 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

INTRODUCTION
A robust internal audit program is an essential requirement for maintaining compliance with ISO 13485:2016 and ensuring the consistent quality and safety of medical devices throughout their lifecycle.

This course equips participants with the knowledge and practical skills needed to plan, conduct, report, and follow up on internal audits systematically and effectively. The training emphasizes understanding process-based auditing, identifying compliance gaps, evaluating the effectiveness of the Quality Management System (QMS), and driving continual improvement within the organization.

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

• Understand the purpose, structure, and key requirements of ISO 13485:2016.
• Explain the principles, responsibilities, and ethics of internal auditors.
• Apply a process-based auditing approach aligned with ISO 19011 guidelines.
• Plan, prepare, and execute internal audits effectively using audit tools and checklists.
• Evaluate evidence, identify nonconformities, and assess process effectiveness.
• Document findings in a clear and objective audit report.
• Verify corrective actions and contribute to continual QMS improvement.
• Strengthen organizational compliance with regulatory and customer requirements through a strong internal audit program.
  

COURSE OUTLINE
1. Introduction to auditing quality management system

• Dilemma of internal quality audit
• Auditing fundamental
• Why audit is essential
• Audit requirements: FDA QSR/ QMSR & ISO 13485:2016
• ISO guideline in auditing management system
• The role of internal quality audit
• Why audit
• What to audit
• Management responsibility
• Management Representative responsibility

2. Types of audit
3. Principles of auditing
4. Internal audit process
5. Application of PDCA in audit process
6. Managing audit program

• Establish program objectives
• Determine audit program risk & opportunities
• Establish audit program
• Implement audit program
• Monitor audit program
• Review & improving audit program

7. Conducting the audit

• Preparing audit
• Conduct audit
• Prepare audit report
• Audit follow up
  

8. Auditor competency
9. The future of internal quality audit
10. Understand ISO 23485:2016 QMS from auditor perspective 

• Introduction
• Mandatory documentation
  
• Clause by clause interpretation from auditor perspective

Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021)

DATE: 20 & 21 April 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course