Category Archives: 2026 Training (Feb – May)

EU Medical Device Regulation (EU MDR 2017/745)

DATE: 20 & 21 May 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

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 OUTLINE
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

Transforming Processes with Creative Thinking & AI

DATE: 20 May 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 1 full-day course

INTRODUCTION
This course employs creative techniques, including the traditional SCAMPER and the non-traditional lateral thinking, random inputs, and generative AI (Gemini), to disrupt and improve legacy business processes. It combines vertical and lateral thinking techniques that enable learners to move from data-driven diagnosis to radical solution architecture. 

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

• Understand the basic structure of an effective Generative AI Prompt.
  
• Construct prompts when using generative AI for Process Data Analysis.
  
• Deploy Six Thinking Hats to systematically drive process improvement.
  
• Break legacy mindsets using the Challenging Assumptions technique.
  
• Generate high-volume, non-obvious solutions using AI-Random Input.
• Document innovations using Mind Mapping.

COURSE OUTLINE
1. The Diagnosis (Data Analysis & Goal Setting): Use AI to find “focus points” in raw process data
2. The Clean Slate (Challenging Assumptions): Use the “Assumption Crusher” prompt & SCAMPER to challenge legacy rules and assumptions
3. Lateral Sparks (Edward de Bono’s Random Input): Use AI to force-link unrelated nouns to process goals
4. The Mind Hub (Mind Mapping): Document the process improvement project into a visual hierarchy diagram
5. The Stress Test (Six Thinking Hats): Assign AI “Hats” to critique solutions (Black/Yellow/Red)
6. The Blueprint (Documentation & Reporting): Convert the Mind Map into a formal Project Charter

Lean Manufacturing

DATE: 18 & 19 May 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

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

• Understand and identify the key principles of Lean Manufacturing.
• Understand and identify the 7 Wastes.
• Develop SIPOC and Value Stream Mapping.
• Utilize the Lean Best Practices to improve productivity.
• Engage your staff or teammates through process values stream mapping, analysis and improvement.
• Differentiate between Lean project and Lean management implementations.

COURSE OUTLINE
1. Introduction to Lean Manufacturing
2. The Operational ‘Waste’ (The 7 Lean Wastes)
3. Value stream map, bottleneck and constraint
4. Lean Best Practices: Takt Time, Kanban, Cell Layout, Schedule Board, Pull, Visual Management and 5S
5. Flow management technique

PREREQUISITE
For effective learning, participants are required to attend the Process Mapping training before attending this Lean Manufacturing training. We will use the data from Process Mapping for Lean Manufacturing.

Medical Device Design Control

DATE: 13 & 14 May 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement design control for medical devices.

COURSE OUTLINE
1. Introduction to design control
2. Application of risk management to design control
3. Design control system

• Design and development planning
• Design and development input
• Design and development output
• Design and development review
• Design and development verification
• Design and Development validation
• Design and development transfer
• Design and development changes
• Design history file

4. Validation system (Design/Installation/Operational and Performance Qualification)
5. Statistical tools and techniques
6. Design control – Quality system inspection technique

COURSE FEES (8% SST included)

Early Bird Price (until 22 Apr 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 23 Apr 2026 onwards)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

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