Category Archives: 2026 Training (Jun – Dec)

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EU Medical Device Regulation (EU MDR 2017/745)

Date: 21 & 22 December 2026 (Mon & Tue)

Time: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

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[/vc_column_text][vc_separator][vc_row_inner][vc_column_inner][vc_column_text]COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 30 November 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 1 December 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 30 November 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 1 December 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

 

Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194

 [/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_btn title=”DOWNLOAD BROCHURE” color=”primary” size=”lg” link=”url:https%3A%2F%2Fammi.com.my%2Fwp-content%2Fuploads%2F2026%2F01%2F2026-EU-Medical-Device-Regulation-EU-MDR-Brochure.pdf|||”][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”REGISTER HERE” color=”success” size=”lg” link=”url:https%3A%2F%2Fform.jotform.com%2F262288617430460|||”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

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Medical Device Single Audit Program

DATE: 16 & 17 December 2026 (Wed & Thur)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

INTRODUCTION
The Medical Device Single Audit Program (MDSAP) was an initiative from the International Medical Device Regulators Forum (IMDRF). Developed to enhance the auditing and monitoring approach of medical devices manufacturing globally, MDSAP went through a 3-year pilot project from 1st January 2014 until 31st December 2016 and became a full program from 1st January 2017.

This MDSAP training provides a comprehensive introduction to the Medical Device Single Audit Program and its regulatory purpose. The course explains the MDSAP framework, audit model, and key requirements, including how MDSAP supports compliance with the regulatory authorities of participating countries. Participants will gain practical insight into audit expectations, preparation strategies, and how to maintain ongoing compliance.

 

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

• Learn the structure and purpose of Medical Device Single Audit Program (MDSAP)
• Gain a good understanding of the seven processes in MDSAP and their interlinkages.
• Learn the MDSAP audit approach.
• Understand the MDSAP certification process.

 

COURSE OUTLINE
1. Background of the MDSAP
2. MDSAP members, official observers, and affiliate members
3. The seven processes in MDSAP
4. Chapter 1 – Management
5. Chapter 2 – Device Marketing Authorization and Facility Registration
6. Chapter 3 – Measurement, Analysis and Improvement
7. Chapter 4 – Medical Device Adverse Events and Advisory Notices Reporting
8. Chapter 5 – Design and Development
9. Chapter 6 – Production and Service Controls
10. Chapter 7 – Purchasing
11. Auditing Organization (AO) and MDSAP certification
12. The MDSAP audit approach and audit time determination[/vc_column_text][vc_separator][vc_row_inner][vc_column_inner][vc_column_text]COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 25 Nov 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 26 Nov 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 25 Nov 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 26 Nov 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194[/vc_column_text][vc_separator][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_btn title=”DOWNLOAD BROCHURE” color=”primary” size=”lg” link=”url:https%3A%2F%2Fammi.com.my%2Fwp-content%2Fuploads%2F2026%2F02%2F2026-Medical-Device-Single-Audit-Program-Brochure.pdf|||”][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”REGISTER HERE” color=”success” size=”lg” link=”url:https%3A%2F%2Fform.jotform.com%2F260331030050434|||”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

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NCR/ CAPA/ Complaint Handling

DATE: 2 & 3 December 2026 (Wed & Thur)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

INTRODUCTION
This course introduces the concepts needed to understand the requirements of NCR, CAPA and complaint handling under ISO 13485:2016 QMS and US FDA Quality Management System Regulation (21 CFR Part 820). It provides guidance on how to address each of them effectively with a step-by-step process that incorporates root cause analysis & problem-solving tools. 

 

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

• Understand requirements: Learn the key regulations and standards on managing NCR, complaint, and CAPA in the medical device industry.
• Handle NCR effectively: Identify, document, and manage nonconformances to maintain product quality.
• Improve complaint handling: Develop skills to investigate and resolve customer complaints efficiently.
  
• Strengthen CAPA process: Implement corrective and preventive actions to prevent recurring issues.
• Ensure compliance: Build systems that meet regulatory requirements and improve operational performance.
  

 

COURSE OUTLINE
1. Standard and regulatory perspective on NCR, complaint handling and CAPA
2. Nonconformance process flow
3. Tips to prevent nonconformance
4. Sample template for nonconformance
5. How to write an effective nonconformance report
6. Complaint handling process flow
7. Rules of complaint handling
8. Tips for effective complaint handling
9. Sample template for complaint handling
10. Differences between correction, corrective action, and preventive action
11. Steps to create risk-based CAPA process
12. Sample template for CAPA 
[/vc_column_text][vc_separator][vc_row_inner][vc_column_inner][vc_column_text]COURSE FEES (8% SST included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 11 November 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 12 November 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 11 November 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 12 November 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

 

Bonus deal for group registration 
For the 6th pax to 9th pax: 30% discount 
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194[/vc_column_text][vc_separator][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_btn title=”DOWNLOAD BROCHURE” color=”primary” size=”lg” link=”url:https%3A%2F%2Fammi.com.my%2Fwp-content%2Fuploads%2F2026%2F01%2F2026-NCR-CAPA-Complaint-Handling-Brochure.pdf|||”][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”REGISTER HERE” color=”success” size=”lg” link=”url:https%3A%2F%2Fform.jotform.com%2F262288433046459|||”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

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Medical Device Manufacturing Process Validation

DATE: 30 Nov & 1 Dec 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the US FDA Quality Management System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.

 

COURSE OUTLINE
1. Validation – ISO and regulatory requirements
2. Validation master plan
3. Risk assessment in process validation
4. Statistical tools and techniques
5. Validation system
6. Process validation
7. Software validation
8. Equipment / Software – DQ/IQ/OQ and PQ
9. Change control
10. Validation – Good Documentation Practices[/vc_column_text][vc_separator][vc_row_inner][vc_column_inner][vc_column_text]COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 9 Nov 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 10 Nov 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 9 Nov 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 10 Nov 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

 

Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194[/vc_column_text][vc_separator][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_btn title=”DOWNLOAD BROCHURE” color=”primary” size=”lg” link=”url:https%3A%2F%2Fammi.com.my%2Fwp-content%2Fuploads%2F2026%2F01%2F2026-Medical-Device-Manufacturing-Process-Validation-Brochure.pdf|||”][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”REGISTER HERE” color=”success” size=”lg” link=”url:https%3A%2F%2Fform.jotform.com%2F261302765369461|||”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

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ISO 13485:2016 Internal Audit

DATE: 30 November & 1 December 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

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

[/vc_column_text][vc_row_inner][vc_column_inner][vc_separator][vc_column_text]COURSE FEES

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 9 November  2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 10 November 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 9 November 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 10 November 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

 

Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_btn title=”DOWNLOAD BROCHURE” color=”primary” size=”lg” link=”url:https%3A%2F%2Fammi.com.my%2Fwp-content%2Fuploads%2F2026%2F01%2F2026-ISO-13485-Internal-Audit-Brochure.pdf|||”][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”REGISTER HERE” color=”success” size=”lg” link=”url:https%3A%2F%2Fform.jotform.com%2F261451783358464|||”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]