Tactical Session working with a Notified Body

MDR & IVDR Tactical Session: working with a Notified Body

by Jasminka Roth on 24 September 2019

Finding, connecting to and working with a MDR designated Notified Body (NB) has a specific trajectory. For many medtech companies this process can currently feel as far away as the moon, particularly SMEs. From the launch to your destination, we are sharing a workshop that can deliver greater insight into this process for manufacturers.

What is a Tactical Session?

This is a hands-on and interactive workshop designed by The Tao of Excellence to deliver immediate insight into specialised topics, leaving you with a series of deliverables that are developed during the session and a plan of action you can be implemented the next day.

This is a proven and well-developed workshop format with an original structure that delivers an in-depth understanding and a tactical strategy by the end of the session.

The topic

This event is dedicated to advising medical device manufacturers on how to:

  • identify the right Notified Body for your product portfolio;
  • connect with the NB and develop a strong regulatory strategy;
  • collaborate with the NB to ensure your certification.

For medical device manufacturers, collaborating with a Notified Body poses new challenges such as, which NB is right for your product? How can you successfully connect with an NB and maintain a good partnership in the long term?—especially given the scarcity of designated NBs. And as an SME, what should you be doing now to ensure that your transition to the MDR / IVDR runs as smoothly as possible?

I will be presenting with our Quality Implementation Manager Deepa Rajagopalan to get to the root of these questions, and we are delighted to be joined by Roger Roth, the Managing Director of ITS (Industrie- und Technozentrum Schaffhausenand), and Stefan Leuthold, the Cluster Manager HTCS (Health Tech Cluster Switzerland).

The event

MDR and IVDR: working with a notified body
Date: Thursday 10th October 2019, 4.30pm – 9pm
Location: ITS Industrie- und Technozentrum Schaffhausen, Freier Platz 10, 2nd floor, 8200 Schaffhausen (Map)

This is a free event with 40 available spaces. Register your place here.

Who is this for?

The event is aimed at Managing Directors, Quality Assurance related roles and decision-makers working in medtech companies.

The program:

4.30 pm: Arrival

5 pm: Welcome and introduction
Roger Roth, Managing Director, ITS
Stefan Leuthold, Cluster Manager, Health Tech Cluster Switzerland

Notified bodies and the challenges of the MDR / IVDR
Jasminka Roth, CEO, The Tao of Excellence GmbH

Regulation versus innovation
Deepa Rajagopalan, Quality Implementation Manager, The Tao of Excellence GmbH

What can you start doing now?
Deepa Rajagopalan, Quality Implementation Manager, The Tao of Excellence GmbH

Workshop: How can you work successfully with a Notified Body?
Jasminka Roth, CEO, Tao of Excellence GmbH
Deepa Rajagopalan, Quality Implementation Manager, The Tao of Excellence GmbH 

Questions and discussion

7–9pm: Aperitif and network

Contact us for more information on our services, or to find out about the “Tactical Session” workshops we can offer. This format can be presented as an open event or a private company session for your team, and there are a set of Tactical Sessions that are already available. These are dedicated to supporting manufacturers during their transition to the MDR / IVDR, and can also be adapted to a range of topics, including clinical data, data literacy, analytics, strategical intelligence and the improvement of company processes and procedures.

Jasminka Roth
Founder and Director of The Tao of Excellence

+41 52 685 51 65

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Jasminka RothMDR & IVDR Tactical Session: working with a Notified Body