10,11,16 and 17 Dec 2020: Risk Management for Medical Devices (ISO14971 : 2019)

Dates: 10,11, 16 and 17 December  2020
Time: 1.30pm – 5.00pm

Online Training

Four Sessions over Four Days (3.5 hours per session)


AMMI Member: RM 1,272.00 per pax (incl 6% SST)
Non Member: RM 1,484.00 per pax (incl 6% SST)

AMMI Member: RM 1,484.00 per pax (incl 6% SST)
Non Member: RM 1,696.00 per pax (incl 6% SST)


Every medical device produced shall be safe to be used and effective. There is no compromise in ensuring every life is protected when they are exposed to medical devices. International standards are published (i.e ISO 13485) and regulations are gazette (i.e Malaysia Medical Device Act and Regulations, the US FDA Code of Federal Regulations, and EU Medical Device Regulations) with an intention to ensure the manufacturing and every dealing (importation and distribution) relating to medical devices are being monitored and controlled.


The ISO 14971 standard is developed to outline a systematic approach on how to identify, manage, and control risk of medical devices from the point of conception and design to the disposal of the medical devices.



This course aims to help delegates to understand the ISO 14971:2019 standard and the course content outlined is to provide delegates with:

  • Examples of risks related to medical devices and its consequences
  • Practical knowledge in analysing, estimating, evaluating, and controlling risk related to medical devices throughout its life cycle



  • Be able to apply ISO 14971 in their respective medical device risk management activities
  • Be able to establish risk matrix for their respective organization
  • Have better understanding on different tools used in risk management (i.e Failure Mode and Effects Analysis – FMEA, Preliminary Hazard Analysis – PHA, Hazard Analysis Critical Control Points – HACCP)



  1. Understand basic principles of risk management
  • Standards & Regulation
  • What is Risk Management
  • The Importance
  • When to Initiate
  • Use of Risk Management


  1. ISO 14971:2019 Requirements
  • Scope
  • Normative Reference
  • Terms and Definition
  • Clause 4.1 Risk Management Process
  • Clause 4.2 Management Responsibilities
  • Clause 4.3 Competence of Personnel
  • Clause 4.4 Risk Management Plan
  • Clause 4.5 Risk Management File
  • Clause 5 Risk Analysis
  • Clause 6 Risk Evaluation
  • Clause 7 Risk Control
  • Clause 8 Evaluation of Overall Residue Risk
  • Clause 9 Risk Management Review
  • Clause 10 Production and Post Production Activities


  1. Highlighted changes in ISO 14971:2019 vs ISO 14971:2012
  2. ALARP Concept
  3. Summary

Kenny Chong is the General Manager at Quintas Consulting Sdn Bhd where his role also includes maintaining top quality training, consultancy and coaching service for Medical Device & other regulated industries.

He has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics, Symmetry Medical, Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes.

He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016. He has also attended and passed training on Conformity Assessment Procedures on Quality Management System & Post Market Surveillance by the Medical Device Authority, Malaysia.


Professionals from quality assurance, regulatory affairs, research and development, process improvement, manufacturing and others who involve and wish to understand how to apply and develop proper risk management documentation for product and process of medical device industry.

Basic understanding of the ISO 13485:2016 and use of risk management tools such as FMEA is an added advantage. Previous knowledge of ISO 14971:2007 or EN ISO 14971:2012 is not required.

All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1:  Direct Bank-in or via E-Banking upon receipt of Invoice

An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

Bank Account Name: Medsociate Sdn Bhd  

Bank Account Number: 230-302-078-2

Bank: UOB Bank          

Swift Code: UOVBMYKL 

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed.

 Option 2: Direct Online Payment
You may choose to make direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option. 

AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded in full if the cancellation is made by AMMI.  No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.


Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee


Replacement of participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347