Risk Management for Medical Devices (EN ISO14971 : 2019)

14-15 July 2020, Penang

RISK MANAGEMENT FOR MEDICAL DEVICES (EN ISO14971:2019)

EARLY BIRD COURSE FEES (until 12 June)
AMMI Member: RM 1,272.00 per pax (inc 6% SST)
Non Member: RM 1,484.00 per pax (inc 6% SST)

 

NORMAL COURSE FEES (from 13 June onwards)
AMMI Member: RM 1,484.00 per pax (inc 6% SST)
Non Member: RM 1,696.00 per pax (inc 6% SST)

INTRODUCTION

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.

 

Main highlighted of the updates are as follows:

  • The key concepts and core approach to risk management was maintained
  • Clarification was added around the following:
  • Production and post-production information
  • Clinical benefits and risk-benefit analysis
  • Update the guidance in the annexes
  • Revise ISO/TR 24971- The Technical Report that provides guidance on the application of ISO 14971

 

  • Informative Annexes would primarily reside in ISO TR 24971 because it is easier to update a Technical Report than it is a standard. A new Clause was added: Clause 2 on Normative References. As a result, all Clauses past Clause 1 are incremented by 1.
  • While the Technical Report compliments the standard, it is important to note that the information in ISO TR 24971:2019 serves only as a guidance, and not requirements. As well, the first 3 annexes in ISO 14971:2019 act as guidance, and not requirements. The ISO/TR 24971:20XX has not been released yet.

 

COURSE OBJECTIVE

This training aims to provide participants with a clear understanding and insight into the new EN ISO 14971:2019 requirements. The training takes a look at what the major changes in 2019 updates/revision and also covers some of the commonly used risk management tools such as FMEA, FTA etc.

 

COURSE OUTLINE

Day 1:

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

 

  1. EN 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

 

Day 2

  1. EN ISO 14971:2019 Background
  2. EN ISO 14971:2019 vs EN ISO 14971:2012 vs EN ISO 14971:2009 vs ISO 14971:2007
  3. Highlighted changes in EN ISO 14971:2019 vs EN ISO 14971:2012
  4. ALARP Concept
  5. Summary

 

TARGET AUDIENCE

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.

 

PRE-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

Two (2) full days

 

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