22-23 September 2022- Risk Management for Medical Devices

Risk Management for Medical Devices (EN ISO 14971:2019)

Date: 22-23 September 2022

Time: 8.30am – 5.30pm (2 full days)

Delivery Mode
Online Training


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



  • EN ISO 14971:2019+A11:2021 Requirements
    • Clause 1 Scope
    • Clause 2 Normative Reference
    • Clause 3 Terms and Definitions
    • Clause 4 General Requirements for Risk Management System
    • Clause 4.1 Risk Mgt 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
  • ISO 14971:2019 vs ISO 14971:2007 (Annex B – ISO 14971:2019)



Upon completion of this training, delegates will: –

  1. Be able to apply ISO 14971 in their respective medical device risk management activities
  2. Be able to establish risk matrix for their respective organization
  3. 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)


This programme is particularly useful to those responsible for medical device risk management especially the management team, designers, product and process responsible personnel, and supply chain personnel.


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.


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 qualifications in 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.





Early Bird Course Fees (Register by 26 August 2022)
AMMI Members: RM1,272 per pax (inc 6% SST)
Non-AMMI Members: RM1,484 per pax (inc 6% SST)

Normal Course Fees (From 27 August 2022 onwards)
AMMI Members: RM1,484 per pax (inc 6% SST)
Non-AMMI Members: RM1,696 per pax (inc 6% SST)

Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.

  • Group Registration Package:
    For group registration of 6 pax and above (up to 9 pax), the fee is RM1,166 per pax (inc 6% SST).
  • Bonus Deal Package:
    For group registration of 10 pax and above (up to 18 pax), the bonus deal are as follows:
    – First 9 pax: RM1,166 per pax (inc 6% SST).
    – 10th pax – 18th pax: RM212 per pax (inc 6% SST).


Option 1: HRDCorp Claimable Course Scheme

A quotation together with course outlines and course agenda will be sent to you for HRDCorp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.


Option 2: Self-paying

2a) Direct Bank-in or via E-Banking

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.


Please refer the following bank account details:

Beneficiary 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.


2b) Direct Online Payment

You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.

The organisers, AMMI/ Medsociate Sdn Bhd 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/ Medsociate Sdn Bhd. 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 Medsociate Sdn Bhd
Authorised training provider of AMMI

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347