The new EU Medical Device & in-vitro Diagnostic Regulations - How does it impact your organisation?

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. Register now with discount code "IAMEARLY" for attractive early-bird discount!


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)


11 July 2017 (Day 2 - IVDR)


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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