Register for "Sharpen Your Skills 2020" - Free Virtual Medical Device Development Seminar


April 28th, 2020 | 09:00 - 12:15 | Free Virtual Seminar

Aligned Seminar

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 2020.

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

Register now to reserve your seat!

We look forward to seeing 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

Perspective of Post-Market Surveillance under MDR

The Medical Device manufacturer’s effort put into Post Market Surveillance (PMS) is increasing drastically under the MDR regime.
The task in front of us appears daunting at best and overwhelming at worst.
Learn from our invited experts on how to collect enough PMS data to stay compliant and efficient at the same time.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

V&V activities are always planned last, that is why they have no right to fail, but from failure, we learn, how can we use testing to our advantage?
Based on the example of an implantable pump, we discuss what kind of verification can and should be done at which stage of development and how it should be documented.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

It is said that 'No battle plan survives the contact with the enemy'. What is the best way to plan and implement IEC 62304 in an efficient and compliant manner?
Learn from the successes and failures of leading medical device manufacturers in Switzerland.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

’Did you assess the risks correctly?’ When your device is a laser for eye surgery, this is a very valid question.
Find out more on how Ziemer Systems structures the risk management file; and integrates device data, post-market surveillance information, clinical data, and much more in a comprehensive risk assessment approach for a complex medical device.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

Key Performance Indicators are widely used by organizations to evaluate their success at reaching critical targets. In the context of Medical Device Technical File documentation, what are examples of good and bad KPIs.
Learn from this session how Requirement Management, Risk Management, Test Management, and Document Management can be monitored using KPIs.

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

Time and Place

  • Date: Tuesday, April 28th
  • Time: 09:00 - 12:15
  • Live Streamed from the Aligned HQ. Sign up to get your access link!

Presentations are held in German. Slides are 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.


Register to get your online access. We are looking forward to seeing you in this virtual seminar!



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.