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Understanding ISO 13485:2016 Clause by Clause

SMF-CCL

Thursday, 21 September 2017 from 09:00 to 17:00 (Singapore Standard Time Singapore Time)

Ticket Information

Type End Quantity
21 Sep 2017, 9am-5pm: Understanding ISO 13485:2016 Clause by Clause $800 Ended Free  
21-22 Sep 2017, 9am-5pm: 2-day Workshop - Understanding ISO 13485:2016 Clause by Clause & Being Audit-Ready for ISO13485:2016 $1,700 Ended Free  

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Event Details

Workshop Schedule

21 September 2017

(1-day workshop)

Understanding ISO 13485:2016 Clause by Clause

$800

21 September 2017 to 22 September 2017

(2-day workshop)

Understanding ISO 13485:2016 Clause by Clause & Being Audit-Ready for ISO 13485:2016

Special Price: $1,700

 

Trainer's Profile

The trainer for this series of workshops is no other than Mr Liew Ee Bin, member of the ISO/TC 210 WG1 drafting committee for ISO 13485:2016. Besides contributing his expertise in medical devices quality management system to ISO/TC 210 WG1, Ee Bin is also very well-versed in many facets of the medical device industry such as company establishment, global regulatory affairs, competence development, strategic marketing and international business development activities. 

 

Understanding ISO 13485:2016 Clause by Clause – From the Expert

 

Introduction

This full day workshop is designed to equip participants with the fundamental knowledge of the ISO 13485:2016 through in-depth clause by clause explanation. Mr Liew Ee Bin, who was one of the authors involved in the revision of this International Standard, will also be sharing on how the ISO 13485:2016 was conceptualised and the differences between the 2003 version and the 2016 version. Participants who are preparing for audit should also sign up for the “Being Audit Ready for ISO 13485:2016” workshop.

 

Who Should Attend?

Professionals in Quality, Regulatory, Executive Management, Manufacturing/Operations, R&D, Product Development, Supply Chain of medical technology companies still planning their transition, medical technology startups, spin-offs, companies aspiring to be in the medical technology industry, and technology transfer offices

 

What will I learn?

  • Structure of the ISO 13485:2016
  • Requirements of ISO 13485:2016
  • What are the differences between ISO 13485:2003 and ISO 13485:2016

 What are the benefits?

  • Understanding the standard is the first step towards ISO 13495:2016 certification
  • Interpret all clauses of ISO 13485:2016
  • Appreciate the importance of quality management system in manufacturing of medical devices

What is included?

  • Training materials
  • Refreshments
  • Certificate of attendance

 

Being Audit Ready for ISO 13485:2016

 

Introduction

This full day workshop is designed for participants who are preparing to implement ISO 13485:2016 for their organisation. Successful implementation of this revised International Standard within the 3-year transition period will require thorough planning, proper training and perfect execution by the entire team. Mr Liew Ee Bin, one of the authors involved in drafting the ISO 13485:2016, will share with participants on how to plan their timeline and resources for transition. Participants who are interested to know more about ISO 13485:2016 should also sign up for the “Understanding ISO 13485:2016 Clause by Clause – From the Expert” workshop. 

 

Who should attend?

Professionals in Quality, Regulatory, Executive Management, Manufacturing/Operations, R&D, Product Development, Supply Chain of medical technology companies still planning their transition, medical technology startups, spin-offs, companies aspiring to be in the medical technology industry, and technology transfer offices

 

 What will I learn?

  • What my organisation needs to do now
  • How to plan the timeline for transition to ISO 13485:2016
  • Requirements to fulfil at each milestone towards transition

 

What are the benefits?

  • First step to a smooth transition to ISO 13485:2016
  • Be in full control of the transition process
  • No last minute panic situation to meet requirements


What is included?

  • Training materials
  • Refreshments
  • Certificate of attendance

 

Mode of Payment

Cheque payment should be made to ‘SMF Centre for Corporate Learning Pte Ltd’ with the participant’s name, course title and course date. Please make full course fees payment at least 3 days before class commencement.

Payment via Cash/NETS may be made during our operating hours: 

Office Hours
9:00am to 6:00pm (Mon - Fri)

Lunch Break
12.30pm to 1.30pm


Do you have questions about Understanding ISO 13485:2016 Clause by Clause? Contact SMF-CCL

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When & Where


Singapore Manufacturing Federation
2985 Jalan Bukit Merah
Level 1, Room E1.4
Singapore 159457
Singapore

Thursday, 21 September 2017 from 09:00 to 17:00 (Singapore Standard Time Singapore Time)


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Understanding ISO 13485:2016 Clause by Clause
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