Register for "Sharpen Your Skills 2019" - Medical Device Development in the MDR Era


Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station

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Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.


Key Learning Objectives

The way to MDR: real world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval is more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as the costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and show possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hands-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Dr. Autumn Lang, CEO, Confinis CPM

Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

Time and Place

  • Date: Tuesday May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.


We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.



Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich



About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.


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