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Workshop: The new EU Medical Device and in-vitro Diagnostics Regulation Banner Image

Workshop: The new EU Medical Device and in-vitro Diagnostics Regulation

How does it impact your Organisation?

Monday, Jul 10, 2017, 08:30 am - Tuesday, Jul 11, 2017, 05:30 pm

NUS Enterprise@Blk71, 71 Ayer Rajah Crescent #02-01, , , Singapore
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Jointly Organised by:

 

  

Stendard, together with TÜV Rheinland and MT Promedt Consulting GmbH, is organising the first-ever tripartite workshop! Come and get first-hand updates on the new Medical Device Regulation (MDR) and in-vitro Diagnostic Regulation (IVDR), what are Notified Bodies looking out for during the audits and how you can leverage on software to help you transit your products from the current directives to the new regulations.

 

Singapore companies eligible for PIC are able to claim 40% off post-discounted tickets. 


About the MDR & IVDR Implementation

As mentioned, the new European Medical Devices Regulation (MDR) and in-vitro Diagnostics Regulation (IVDR) have been finalised and published in the Official Journal of the European Union, as Regulation 2017/745 and 2017/746 respectively. The Regulations will enter into force on May 25th 2017, marking the start of the transition period for companies selling medical devices into Europe.

 

How to get your organisation ready?

We are excited to announce that we have organised a two full-days’ workshops, not only just focusing on the MDR & IVDR updates, but we will also be discussing on the possible implementation strategies for your organisation!

Guest Speakers:

Dr Michael Rinck (MT Promedt Consulting GmbH, Germany)
Mr Clemens Mohr (MT Promedt Consulting GmbH, Germany)
Ms Jocelyn Reyes (TÜV Rheinland, Singapore)
Mr Jason Lim (Stendard, Singapore)

 

Workshop Schedule

10 July 2017 (Day 1 – MDR)

8.30am – 9.00am

Registration & Networking

9.00am – 4.00pm

Mr Clemens Mohr
Director

MT Promedt Consulting GmbH

  • General introduction to MDR
  • Changes to MDD
  • CE marking under MDR
  • Technical Documentation
  • Quality Management System requirements under the MDR
  • Documentation requirements
  • Conformity assessment procedures
  • Post market surveillance and post market clinical follow-up
  • Implementation strategy

4.00pm – 5.00pm

Ms Jocelyn Reyes
Auditor, Medical Devices

TÜV Rheinland (Singapore)

  • Expectation for companies transiting to the new MDR 2017/745
  • Timeline for Notified Bodies to begin audit based on new MDR (3 years transition period)

5.00pm – 5.30pm 

Mr Jason Lim
CEO and Co-founder

Stendard

  • How can Stendard help to smoothen my transition to the new MDR 2017/745 and ISO 13485:2016?

 

11 July 2017 (Day 2 – IVDR)

8.30am – 9.00am

Registration & Networking

9.00am – 4.00pm

Dr Michael Rinck
Managing Director and Founder

MT Promedt Consulting GmbH

  • General introduction to IVDR
  • Changes to IVDD
  • CE marking under IVDR
  • Technical Documentation
  • Quality Management System requirements under the IVDR
  • Documentation requirements
  • Conformity assessment procedures
  • Post market surveillance and post market clinical follow-up
  • Implementation strategy

4.00pm – 5.00pm

Ms Jocelyn Reyes
Auditor, Medical Devices

TÜV Rheinland (Singapore)

  • Expectation for companies transiting to the new IVDR 2017/746
  • Timeline for Notified Bodies to begin audit based on new IVDR (5 years transition period)

5.00pm – 5.30pm

Mr Jason Lim
CEO and Co-founder

Stendard

  • How can Stendard help to smoothen my transition to the new IVDR 2017/746 and ISO 13485:2016?

 

Workshop Pricing

One-day pass for MDR Workshop – S$390
One-day pass for IVDR Workshop – S$390
Two-days passes for both Workshop – S$690
All prices include lunch and refreshments.

* Singapore companies eligible for PIC are able to claim 40% off post-discounted tickets.

 

Importance of attending this workshop

In these newly implemented Regulations, some of the major changes include processes changes within the quality management system (QMS), scrutiny on the assessment of product safety and performance, and stricter requirements on clinical evaluation and post-market clinical follow-up. For IVD devices, the previous Directive allows almost 80% of the devices to be marketed via the self-declaration route. This is totally reversed in the new IVDR, where almost all of these IVD devices have to be evaluated by Notified Bodies now.

During this workshop, we would get to learn from our guest speakers:

  • Dr Michael Rinck and Mr Clemens Mohr from MT Promedt Consulting GmbH, Germany - about first hand news on the new regulations, as well as recommendations on how you should transit from the current directives to the new regulations!
  • On top of that, we have also invited Ms Jocelyn Reyes, Medical Device Auditor at TÜV Rheinland to share about the expectations from the viewpoint of a Notified Body and the effective period of transition.
  • Lastly, Mr Jason Lim, CEO of Stendard would also share how your organisation can better manage your Quality Management System processes through the adoption of software and how Stendard can guide and smoothen your organisation’s transition into the new regulations.

With so much knowledge and content put together from these industry experts, you will definitely be well equipped with the necessary information to plan for your organisation’s transition after this!

So do not hesitate further - Register now!


 

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