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22 October 2026 to 21 December 2026: Medtech Professional Certificate in Manufacturing Excellence (ME-Hybrid-3)

Medtech Professional Certificate in Manufacturing Excellence

(ME-Hybrid-3)

DATE: 22 October 2026 to 21 December 2026

TIME: 9.00am – 5.15pm

DURATION: 10-full-day course

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

COURSE DESCRIPTION / OBJECTIVES
The Medtech Professional Certificate in Manufacturing Excellence aims to enhance the knowledge and skills of current employees in medical device manufacturing operation. They will learn about product life cycle management and how to improve the operation system by eliminating waste, improve current process through process mapping, comply with process validation requirements, use statistics to validate assumptions and root causes, identify process instability and develop improvement strategies, evaluate the quality of measurement systems, determine the relationship between factors affecting a process & address non-conformances and product complaint.

 

TARGET PARTICIPANTS:
This course aims to train manufacturing professionals.

 

COURSE OUTLINE
1. Lean Manufacturing (2 days)

  • The operational ‘waste’ (The 7 lean wastes)
  • Lean best practices

2. Process Mapping (1 day)

  • Process mapping tools and process analysis tools
  • Strategies to improve current ‘as is’ process

3. Medical Device Manufacturing Process Validation (2 days)

  • Validation Master Plan
  • IQ , OQ & PQ

4. Hypothesis Testing (1 day)

  • Hypothesis testing with comparative methods
  • Correlation and regression analysis

5. Statistical Process Control and Capability Analysis (1 day)

  • Control charts
  • Methods to determine the current process capability

6. Measurement System Analysis (1 day)

  • Gage repeatability and reproducibility
  • Attribute agreement analysis

7. Design of Experiments (1 day)

  • Factorial design and analysis for experimentation
  • Process model for process prediction and simulation

8. NCR / CAPA / Complaint Handling (1 day)

  • Standard and regulatory perspective
  • Step-by-step process to address non-conformance, CAPA and complaint

10-DAY COURSE FEES (8% SST included)

Option 1: Iconic Marjorie Hotel, Penang and Eastin Hotel, Penang
AMMI Member: RM 9,990.00
Public: RM 11,070.00

Option 2: Online (via Zoom)
AMMI Member: RM 8,262.00
Public: RM 9,342.00

 

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

DOWNLOAD BROCHURE
REGISTER HERE
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19 October 2026 to 17 December 2026: Medtech Professional Certificate in Quality Assurance (QA-Hybrid-3)

Medtech Professional Certificate in Quality Assurance

(QA-Hybrid-3)

DATE: 19 October 2026 to 17 December 2026

TIME: 9.00am – 5.15pm

DURATION: 10-full-day course

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

COURSE DESCRIPTION / OBJECTIVES
The Medtech Professional Certificate in Quality Assurance aims to enhance the knowledge and skills of current employees in quality management system. They will learn how to ensure compliance with the latest US FDA Quality Management System Regulation (QMSR) and EU Medical Device Regulation (EUMDR), develop proper risk management documentation, address and handle non-conformances and product complaint, perform effective investigation to get to the root cause of a problem & manage incoming and outgoing inspection using acceptance sampling method.

 

TARGET PARTICIPANTS:
This course aims to train quality assurance professionals.

 

COURSE OUTLINE
1. Medical Device Quality System: ISO 13485:2016 & US FDA Quality Management System Regulation (2 days)

  • Interpretation of the ISO 13485:2016 and QMSR requirements
  • FDA inspection – The expectation and preparation

2. EU Medical Device Regulation (EU MDR 2017/745) (2 days)

  • Classification rules of medical devices
  • Technical documentation (Annex II & III of EU MDR)
  • Conformity assessment procedures

3. Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021) (2 days)

  • EN ISO 14971:2019/A11:2021 requirements
  • Risk management tools

4. NCR / CAPA / Complaint Handling (2 days)

  • Standard & regulatory perspective on NCR, CAPA & complaint handling
  • Step-by-step process to address non-conformance, CAPA and complaint

5. Effective Root Cause Analysis (1 day)

  • Principles and techniques of effective root cause analysis
  • Common barriers to root cause analysis and techniques to overcome it

6. Acceptance Sampling Method (1 day)

  • Selection of a suitable acceptance sampling plan
  • Designing a sampling plan

10-DAY COURSE FEES (8% SST included)

Option 1: Iconic Marjorie Hotel, Penang
AMMI Member: RM 9,990.00
Public: RM 11,070.00

Option 2: Online (via Zoom)
AMMI Member: RM 8,262.00
Public: RM 9,342.00

 

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

DOWNLOAD BROCHURE
REGISTER HERE
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14 – 15 December 2026: FDA QSR to QMSR: Understanding FDA’s New Requirements & Inspection Expectation

FDA QSR to QMSR: Understanding FDA’s New Requirements & Inspection Expectation

DATE: 14 & 15 December 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
The U.S. FDA has introduced the Quality Management System Regulation (QMSR) to modernize medical device quality system requirements and align them more closely with ISO 13485. This regulatory transition marks a significant shift from the traditional Quality System Regulation (QSR) framework and will directly impact how manufacturers design, implement, and demonstrate compliance during FDA inspections.

This training provides a structured and practical understanding of the QSR-to-QMSR transition, highlighting key regulatory changes, inspection focus areas, and compliance expectations. Participants will gain clarity on what has changed, what remains, and how to prepare their quality systems and organizations for FDA inspections under the new QMSR environment.

 

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

  • Understand the regulatory intent and structure of FDA’s Quality Management System Regulation (QMSR).
  • Explain the key differences and alignments between legacy QSR (21 CFR 820) and QMSR.
  • Identify new and modified FDA requirements resulting from ISO 13485 incorporation.
  • Interpret FDA inspection expectations under QMSR.
  • Assess the impact of QMSR on existing quality system processes.
  • Recognize common inspection risks and compliance gaps during the transition period.
  • Prepare an effective QMSR transition and inspection readiness strategy.

 

COURSE OUTLINE
1. Introduction of US FDA

  • The US Food and Drug Administration (FDA)
  • The Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • The Code of Federal Regulations (CFR)
  • Importance of compliance with US FDA QMSR

2. Quality Management System Regulation

  • Introduction
  • Overall highlight of main changes
  • Summary of key changes
  • QSR vs QMSR section comparison
  • QMSR section by section requirements interpretation

3. FDA inspection

  • Introduction
  • FDA inspection flow
  • QSIT (Quality System Inspection Technique)- How FDA traditionally inspected (Pre-February 2026)
  • The new QMSR inspection era: What replaced QSIT (Post-February 2026)
  • What’s changing in QMSR inspection
  • Key QMSR requirements with inspection implications
  • Expectation and preparation: Pre-inspection & during inspection (do’s & don’ts)
  • FDA inspection outcome
  • Response to FDA observations/ Form 483

4. Executive summary for medical device manufacturer

5. Extra information

  • Gap analysis – Identification of current QSR documentation to be removed & maintained under the new QMSR framework.
  • Gap analysis – FDA QSR vs. FDA QMSR vs. ISO 13485:2016
  • FDA QMSR readiness checklist (For QSR to QMSR transition)

 

COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 23 November 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 24 November 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 23 November 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 24 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

DOWNLOAD BROCHURE
REGISTER HERE
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Export of Made in Malaysia Medical Devices to Cross RM23 Billion in 2019

KUALA LUMPUR, Dec 6 : The Association of Malaysian Medical Industries (AMMI) is projecting exports of medical devices from Malaysia to record a year-on-year growth of eight per cent and  cross RM23 billion in 2019.

The findings of a recent survey by the association revealed that 50 per cent of its members were optimistic of double-digit export growth and Malaysia would continue to evolve as a hub for medical device manufacturing, with over 200 medical device manufacturing companies thriving within a well-connected industry ecosystem.

“The on-going trade war between the United States and China will have a positive impact on Malaysia,” it said in a statement.

AMMI Chairman Christophe Marque said combined export sales of AMMI members rose to RM11.4 billion, up from RM9.7 billion, recorded in the previous year.

“This outpaces most global indices, with a healthy 16.3 per cent compound annual growth rate (CAGR) between 2013 and 2017,” he said.

AMMI also disclosed that its Medical Device Industry Status and Outlook Report 2018/2019, which is based on a survey of 46 AMMI members, highlighted that 74 per cent of them had future expansion plans in the pipeline involving buildings, machinery, equipment, facilities and product lines.

The combined projected value of these foreseeable future expansion plans were about RM1.5 billion.

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Eksport Peranti Perubatan Naik

As featured on Utusan Online, 6 December 2018

KUALA LUMPUR 6 Dis. – Jumlah eksport bagi peranti perubatan Malaysia dijangka menjangkau RM23 bilion pada 2019 atau peningkatan lapan peratus tahun ke tahun, menurut analisis yang dijalankan Persatu­an Industri Perubatan Malaysia (AMMI).

Pengerusi AMMI, Christophe Marque berkata, berdasarkan kaji selidik yang dijalankan terhadap 46 ahli AMMI, 50 peratus daripadanya yakin dapat merekodkan pertumbuhan dua digit dalam jualan eksport yang merupakan antara kesan positif daripada perang dagangan antara Amerika Syarikat (AS) dan China.

Katanya, Malaysia juga terus mengukuhkan kedudukan sebagai hab pembuatan peranti perubatan dengan lebih daripada 200 syarikat perkilangan berkaitan industri berkenaan berkembang dalam ekosistem industri yang baik.

“Apa yang paling mengagumkan adalah sejumlah RM3.43 bilion atau 59 peratus bahan mentah dan perkhidmatan diperoleh dari Malaysia.

“Ini mencerminkan komitmen AMMI dalam menyokong inisiatif kerajaan untuk membangunkan perusahaan kecil dan sederhana (PKS) tempatan,” katanya dalam kenyataan di sini hari ini.

Laporan itu juga menekankan bahawa 74 peratus anggota AMMI mempunyai pelan pengembangan masa depan dalam perancangan, yang melibatkan bangunan, jentera, peralatan, kemudahan dan barisan produk. “Nilai unjuran yang dianggarkan bagi pelan pengemba­ngan masa depan adalah kira-kira RM1.5 bilion,” katanya.

Laporan itu juga menyebut jumlah pelaburan terkumpul oleh responden kaji selidik berkenaan setakat Disember 2017 adalah RM7 bilion, berbanding RM3.4 bilion yang direkodkan pada 2013. Secara keseluruhan Marque berkata, jumlah pelaburan terkumpul bagi 2017 adalah RM967.9 juta berbanding RM215.2 juta pada 2013.

Sementara itu, mengulas mengenai laporan AMMI itu, Ketua Pegawai Eksekutif Lembaga Pembangunan Pelaburan Malaysia (MIDA), Datuk Azman Mahmud berkata, industri peranti perubatan menyaksikan pelaburan baharu dan pengembangan berterusan oleh pemain industri domestik dan asing. Katanya, trend ini dijangka kekal pada tahun-tahun akan datang dengan para pelabur menunjukkan keyakinan yang mantap dalam prospek industri.  “Syarikat-syarikat, terutama pemain tempatan, mesti memanfaatkan kelebihan daya saing dan perbandingan dalam asas komprehensif elektrik dan elektronik, mesin dan kelengkapan selain jaringan rangkaian pembekal tempatan yang kukuh,” katanya.

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