No. |
Training Provider |
Training Topic |
Contact Person |
Contact Details |
1. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Manufacturing Excellence |
Ms Heng Ee Ling |
learning@ammi.com.my |
2. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Quality Assurance |
Ms Heng Ee Ling |
learning@ammi.com.my |
3. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Regulatory Affairs |
Ms Heng Ee Ling |
learning@ammi.com.my |
4. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Medical Device Industry (Fundamental) |
Ms Heng Ee Ling |
learning@ammi.com.my |
5. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Production (Fundamental) |
Ms Heng Ee Ling |
learning@ammi.com.my |
6. |
Association of Malaysian Medical Industries (AMMI) |
21 CFR Part 820 / Quality Management System Regulation (QMSR) |
Ms Heng Ee Ling |
learning@ammi.com.my |
7. |
Association of Malaysian Medical Industries (AMMI) |
US FDA Quality Management System Regulation (QMSR) |
Ms Heng Ee Ling |
learning@ammi.com.my |
8. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Regulation (EU) 2017/745 |
Ms Heng Ee Ling |
learning@ammi.com.my |
9. |
Association of Malaysian Medical Industries (AMMI) |
EN ISO 14971 Risk Management |
Ms Heng Ee Ling |
learning@ammi.com.my |
10. |
Association of Malaysian Medical Industries (AMMI) |
NCR / CAPA / Complaint Handling |
Ms Heng Ee Ling |
learning@ammi.com.my |
11. |
Association of Malaysian Medical Industries (AMMI) |
Effective Root Cause Analysis |
Ms Heng Ee Ling |
learning@ammi.com.my |
12. |
Association of Malaysian Medical Industries (AMMI) |
Acceptance Sampling Method |
Ms Heng Ee Ling |
learning@ammi.com.my |
13. |
Association of Malaysian Medical Industries (AMMI) |
Lean Manufacturing |
Ms Heng Ee Ling |
learning@ammi.com.my |
14. |
Association of Malaysian Medical Industries (AMMI) |
Process Mapping |
Ms Heng Ee Ling |
learning@ammi.com.my |
15. |
Association of Malaysian Medical Industries (AMMI) |
Process Validation |
Ms Heng Ee Ling |
learning@ammi.com.my |
16. |
Association of Malaysian Medical Industries (AMMI) |
Hypothesis Testing |
Ms Heng Ee Ling |
learning@ammi.com.my |
17. |
Association of Malaysian Medical Industries (AMMI) |
Statistical Process Control and Capability Analysis |
Ms Heng Ee Ling |
learning@ammi.com.my |
18. |
Association of Malaysian Medical Industries (AMMI) |
Measurement System Analysis |
Ms Heng Ee Ling |
learning@ammi.com.my |
19. |
Association of Malaysian Medical Industries (AMMI) |
Design of Experiments |
Ms Heng Ee Ling |
learning@ammi.com.my |
20. |
Association of Malaysian Medical Industries (AMMI) |
Fundamentals of Global Medical Device Regulatory System (major markets including ASEAN) |
Ms Heng Ee Ling |
learning@ammi.com.my |
21. |
Association of Malaysian Medical Industries (AMMI) |
Role of the Regulatory Professional & Medical Device Regulatory Process Planning |
Ms Heng Ee Ling |
learning@ammi.com.my |
22. |
Association of Malaysian Medical Industries (AMMI) |
Malaysia Medical Device Regulations |
Ms Heng Ee Ling |
learning@ammi.com.my |
23. |
Association of Malaysian Medical Industries (AMMI) |
US FDA Pre-Market Requirements |
Ms Heng Ee Ling |
learning@ammi.com.my |
24. |
Association of Malaysian Medical Industries (AMMI) |
Change Control and Product Safety |
Ms Heng Ee Ling |
learning@ammi.com.my |
25. |
Association of Malaysian Medical Industries (AMMI) |
ISO 13485:2016 Quality Management System |
Ms Heng Ee Ling |
learning@ammi.com.my |
26. |
Association of Malaysian Medical Industries (AMMI) |
ISO 13485:2016 Internal Audit |
Ms Heng Ee Ling |
learning@ammi.com.my |
27. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Single Audit Programme (MDSAP) |
Ms Heng Ee Ling |
learning@ammi.com.my |
28. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Identification, Classification and Labelling |
Ms Heng Ee Ling |
learning@ammi.com.my |
29. |
Association of Malaysian Medical Industries (AMMI) |
Software Validation Requirements and Excel Spreadsheet Validation |
Ms Heng Ee Ling |
learning@ammi.com.my |
30. |
Association of Malaysian Medical Industries (AMMI) |
Test Method Validation |
Ms Heng Ee Ling |
learning@ammi.com.my |
31. |
Association of Malaysian Medical Industries (AMMI) |
Design Control |
Ms Heng Ee Ling |
learning@ammi.com.my |
32. |
Association of Malaysian Medical Industries (AMMI) |
Change Control |
Ms Heng Ee Ling |
learning@ammi.com.my |
33. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Usability (Human Factor Engineering) |
Ms Heng Ee Ling |
learning@ammi.com.my |
34. |
Association of Malaysian Medical Industries (AMMI) |
Ethylene Oxide Sterilization |
Ms Heng Ee Ling |
learning@ammi.com.my |
35. |
Association of Malaysian Medical Industries (AMMI) |
Gamma Radiation Sterilization |
Ms Heng Ee Ling |
learning@ammi.com.my |
36. |
Association of Malaysian Medical Industries (AMMI) |
Bioburden Test and Test of Sterility |
Ms Heng Ee Ling |
learning@ammi.com.my |
37. |
Association of Malaysian Medical Industries (AMMI) |
Cleanroom and Associated Control Environments |
Ms Heng Ee Ling |
learning@ammi.com.my |
38. |
Association of Malaysian Medical Industries (AMMI) |
Malaysia Good Distribution Practice for Medical Device (GDPMD) |
Ms Heng Ee Ling |
learning@ammi.com.my |
39. |
Association of Malaysian Medical Industries (AMMI) |
GDPMD Internal Audit |
Ms Heng Ee Ling |
learning@ammi.com.my |
40. |
Association of Malaysian Medical Industries (AMMI) |
Good Documentation Practices |
Ms Heng Ee Ling |
learning@ammi.com.my |
41. |
Association of Malaysian Medical Industries (AMMI) |
Failure Modes and Effects Analysis (FMEA) |
Ms Heng Ee Ling |
learning@ammi.com.my |
42. |
Association of Malaysian Medical Industries (AMMI) |
Supply Chain Management (Medical Device Industry) |
Ms Heng Ee Ling |
learning@ammi.com.my |
43. |
Association of Malaysian Medical Industries (AMMI) |
IEC 62304 Sodtware of Medical Device |
Ms Heng Ee Ling |
learning@ammi.com.my |
44. |
Association of Malaysian Medical Industries (AMMI) |
6S for Visual Workplace: Foundation for Lean Manufacturing & Workplace Organization for Medical Device Manufacturers |
Ms Heng Ee Ling |
learning@ammi.com.my |
45. |
Association of Malaysian Medical Industries (AMMI) |
Cost of Quality |
Ms Heng Ee Ling |
learning@ammi.com.my |
46. |
Center for Innovation in Medical Engineering |
Development of Good Distribution Practice for Medical Devices (GDPMD) |
Dr Nurul Fauzani |
cime@um.edu.my |
47. |
Center for Innovation in Medical Engineering |
ISO 13485 – Medical Devices Quality Management Systems |
Dr Nurul Fauzani |
cime@um.edu.my |
48. |
Center for Innovation in Medical Engineering |
ISO 14971 – Medical Devices Application of Risk Management to Medical Devices |
Dr Nurul Fauzani |
cime@um.edu.my |
49. |
Center for Innovation in Medical Engineering |
Medical Device Disposal MS 2650:2015 |
Dr Nurul Fauzani |
cime@um.edu.my |
50. |
Center for Innovation in Medical Engineering |
Medical Device Act 2012 (Act 737) |
Dr Nurul Fauzani |
cime@um.edu.my |
51. |
Center for Innovation in Medical Engineering |
Requirements Atomic Energy Licensing Act 1984 (Act 304) |
Dr Nurul Fauzani |
cime@um.edu.my |
52. |
Center for Innovation in Medical Engineering |
MS 2058 – Code of Practice for Good Engineering Maintenance Management of Active Medical Devices |
Dr Nurul Fauzani |
cime@um.edu.my |
53. |
Center for Innovation in Medical Engineering |
CCM 4 – Introduction to Healthcare, Medical Device Safety and Risk Management |
Dr Nurul Fauzani |
cime@um.edu.my |
54. |
Center for Innovation in Medical Engineering |
IEC 62353 Medical Electrical Equipment – recurrent test and test after repair of ME equipment |
Dr Nurul Fauzani |
cime@um.edu.my |
55. |
Center for Innovation in Medical Engineering |
MS 2739 – Code of Practice – Requirements for Installation, Testing and Comissioning and Acceptance of Medical Device |
Dr Nurul Fauzani |
cime@um.edu.my |
56. |
Center for Innovation in Medical Engineering |
Medical Device Risk Classification & Grouping |
Dr Nurul Fauzani |
cime@um.edu.my |
57. |
Center for Innovation in Medical Engineering |
Duties & Obligations of Establishment: Post-Market Activities |
Dr Nurul Fauzani |
cime@um.edu.my |
58. |
Center for Innovation in Medical Engineering |
Registration of Conformity Assessment Body (CAB) |
Dr Nurul Fauzani |
cime@um.edu.my |
59. |
Center for Innovation in Medical Engineering |
IEC Standards Drive Sustainability of Healthcare Industries |
Dr Nurul Fauzani |
cime@um.edu.my |
60. |
Center for Innovation in Medical Engineering |
Non-ionizing Radiation Safety and Application on Laser |
Dr Nurul Fauzani |
cime@um.edu.my |
61. |
Center for Innovation in Medical Engineering |
ICT in Healthcare |
Dr Nurul Fauzani |
cime@um.edu.my |
62. |
Center for Innovation in Medical Engineering |
Code of Practice for Good Engineering Maintenance |
Dr Nurul Fauzani |
cime@um.edu.my |
63. |
Center for Innovation in Medical Engineering |
Management of Active Medical Devices |
Dr Nurul Fauzani |
cime@um.edu.my |
64. |
Smart Management Consultancy & Resources Sdn Bhd |
Mastering Medical Device Regulation: A Course on Process Validation and Compliance |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
65. |
Smart Management Consultancy & Resources Sdn Bhd |
Advanced Sterilization Techniques and Protocols for Medical Devices |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
66. |
Smart Management Consultancy & Resources Sdn Bhd |
Implementing Medical Device Cybersecurity Best Practices |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
67. |
Smart Management Consultancy & Resources Sdn Bhd |
Risk Management for Medical Devices: ISO 14971 Application |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
68. |
Smart Management Consultancy & Resources Sdn Bhd |
Biocompatibility Testing in Medical Device Development |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
69. |
Smart Management Consultancy & Resources Sdn Bhd |
Regulatory Pathways for Medical Device Approval in ASEAN Markets |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
70. |
Smart Management Consultancy & Resources Sdn Bhd |
Effective Process Validation in Quality Management Systems |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
71. |
SaniChem Resources Sdn Bhd |
Fundamentals of Bioburden Testing: Principles and Relevance in the Medical Device Industry |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
72. |
SaniChem Resources Sdn Bhd |
Practical Skills and Analysis in Bioburden Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
73. |
SaniChem Resources Sdn Bhd |
Advanced Bioburden Testing Techniques and Problem-solving |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
74. |
SaniChem Resources Sdn Bhd |
Endotoxin Testing Essentials |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
75. |
SaniChem Resources Sdn Bhd |
Fundamentals of Sterility Testing: Principles and Importance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
76. |
SaniChem Resources Sdn Bhd |
Fundamentals of EO Residual Testing: Principles and Importance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
77. |
SaniChem Resources Sdn Bhd |
Training on ISO 13485:2016 Medical Device Quality Management System (MDQMS) Awareness |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
78. |
SaniChem Resources Sdn Bhd |
Sterilization: Awareness Training in ISO 11137 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
79. |
SaniChem Resources Sdn Bhd |
Sterilization: Awareness Training in ISO11607-1 and ISO 11607-2 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
80. |
SaniChem Resources Sdn Bhd |
Ethylene Oxide Sterilization: Awareness Training in ISO 11135:2014 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
81. |
SaniChem Resources Sdn Bhd |
Awareness Training in ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
82. |
SaniChem Resources Sdn Bhd |
Introduction to ISO 17025 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
83. |
SaniChem Resources Sdn Bhd |
Moist Heat Sterilization: Awareness Training in ISO 17665-1:2006 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
84. |
SaniChem Resources Sdn Bhd |
Mastering Endotoxin Testing (Kinetic Turbidimetric) Techniques |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
85. |
SaniChem Resources Sdn Bhd |
Advanced Endotoxin Testing (Kinetic Turbidimetric) and Regulatory Compliance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
86. |
SaniChem Resources Sdn Bhd |
Practical Skills and Analysis in Sterility Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
87. |
SaniChem Resources Sdn Bhd |
Advanced Sterility Testing and Regulatory Compliance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
88. |
SaniChem Resources Sdn Bhd |
Sterilization: Awareness Training in ISO 11137 (4 days) |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
89. |
SaniChem Resources Sdn Bhd |
Validation and Verification Test Method Training |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
90. |
SaniChem Resources Sdn Bhd |
Practical and Analysis in Ethylene Oxide Residual Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
91. |
SaniChem Resources Sdn Bhd |
Control Room: Evaluate possible sources of microorganisms and potential to impact product bioburden |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
92. |
SaniChem Resources Sdn Bhd |
Extraction for Ethylene Oxide Residual Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |