Category Archives: 2026 Training

Medical Device Single Audit Program

DATE: 12 & 13 August 2026

VENUE: Dorsett Grand Subang Hotel, Selangor

TIME: 9.00am – 5.15pm

DURATION: 2 full-day course

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

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

EU Medical Device Regulation (EU MDR 2017/745)

DATE: 5 & 6 August 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 2 full-day course

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

Medical Device Change Control

DATE: 20 & 21 July 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 change 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

Design of Experiments

DATE: 30 June 2026

TIME: 9.00am – 5.15pm

VENUE: Olive Tree Hotel, Penang

DURATION: 1 full-day course

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

• Differentiate traditional experimentation and Design of Experiments (DOE) methods.
• Understand and apply crucial DOE concepts.
• Plan a full factorial or a fractional factorial experiment.
• Analyze DOE results.
• Handle confounding effects.
• Develop process models for process predictions and simulations.
• Use Minitab software for DOE analysis.
  

COURSE OUTLINE
1. Types of experimentations
2. Minitab navigation
3. Factorial design and analysis for experimentation
4. Develop process models for process performance prediction and simulations
5. Statistical process control