EN ISO14971 : 2019 -Transition and Changes

31 March 2020, Penang

EN ISO14971:2019 – TRANSITION AND CHANGES

EARLY BIRD COURSE FEES (until 9 March 2020)

AMMI Members: RM 636 per pax (inc 6% SST)
Non Members: RM 742 per pax (inc 6% SST)

 NORMAL COURSE FEES (from 10 March 2020 onwards)

AMMI Members: RM 742 per pax (inc 6% SST)
Non Member:s RM 848.00 per pax (inc 6% SST)

OVERVIEW

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

COURSE OUTLINE

  1. Introduction
  • History
  • Reason of Updated Revision
  • CEN’s Response to ISO 14971:2019
  • Implication for Annexes Z
  • Outstanding Question about ISO 14971:2019

2. Highlight of ISO 14971:2019

3. Potential Changes of ISO /TR 24971:20XX

4. Difference on Structure and Content of ISO 14971:2007 vs ISO 14971:2019

5. Comparison table of ISO 14971:2007 vs ISO 14971:2019

6. Major Clause Changes in ISO 14971:2019

7. Clause by Clause Interpretation of ISO 14971:2019

8. Annexes Interpretation of ISO 14971:2019

9. Extra Information- Minor Changes on Terms and Definition


RE-REQUISITES
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.

DURATION
One (1) full day

TRAINER’S PROFILE
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.

PAYMENT AND CONFIRMATION OF REGISTRATION

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:

Beneficiary Name: Medsociate Sdn Bhd  

Bank Account Number: 800 3930 348

Bank: CIMB Bank          

Swift Code: CIBB MYKL 

 

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.

 

CANCELLATION / REFUND POLICY

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

 

SUBSTITUTION

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.

 

CONTACT

For enquiries, please email to secretariat@ammi.com.my

Tel: +6010 4040 662  Fax: +603 2178 4347