Risk Management for Medical Devices (EN ISO14971:2019)
17-18 March 2021
8.30am – 12.30pm
2 half-day courses (4 hours per session)
ISO 14971 is an ISO standard for the application of risk management to medical devices. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019 to replace the ISO 14971:2007 and EN ISO 14971:2012 respectively.
This course provides an introduction to the key elements of Risk Management for Medical Devices and aims to give you a practical foundation in the relationship between risk management, the regulatory requirements and your Quality Syste
This training is to create awareness of requirements and to have better understanding of the new EN ISO 14971:2019 requirements.
Session 1 (half-day):
- Understand basic principles of risk management
- Standards & Regulation
- What is Risk Management
- The Importance
- When to Initiate
- Use of Risk Management
- EN ISO 14971:2019 Requirements
- Clause 1 Scope
- Clause 2 Normative Reference
- Clause 3 Terms and Definitions
- Clause 4 General Requirements for Risk Management System
- 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
Session 2 (half-day)
- EN ISO 14971:2019 Background
- EN ISO 14971:2019 vs EN ISO 14971:2012 vs EN ISO 14971:2009 vs ISO 14971:2007
- Difference structure and Content of ISO 14971:2007 vs ISO 14971:2019
- Highlighted changes in EN ISO 14971:2019 vs EN ISO 14971:2012
- Change of ISO / TR 24971:2020
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.
Harry Wong has over 19 years’ of professional work experience in Quality Assurance of medical device, Ceramic Former and Metal Stamping for Electrical, Electronics and Automotive industries. He currently holds the position of Associate Director, Global Complaint and Risk Management, Global Quality Assurance in one of the global leaders in protection solutions. As the subject matter expert of risk management, he provides advice, direction and training for Risk Management personnel across global sites and facilities; ensuring their risk management process complies with all necessary regulatory standards including QSR (FDA), MDD and ISO requirements. He is responsible for developing the global harmonized risk management SOP and tools which are implemented in the global organization facilities and sites.
Harry Wong is also an ASQ Certified Quality Engineer and Lead Auditor for ISO 9001 and ISO 13485 and has extensive involvement in mock audits for global sites preparing for CCC, ANVISA, SEI and FDA.
Early Bird Prices (Register by 5 March 2021)
AMMI Member: RM636.00 per pax (incl 6% SST)
Non Member: RM 742.00 per pax (incl 6% SST)
Normal Fees (Register from 6 March 2021 onwards)
AMMI Member: RM 742.00 per pax (incl 6% SST)
Non Member: RM848.00 per pax (incl 6% SST)
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 (email@example.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.
Option 2: Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with the 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.