April 28th, 2020 | 09:00 - 12:15 | Free Virtual 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 expert to share their latest best practices on how to eliminate problems with you.
Register now to reserve your seat!
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 a 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 Ophtalmic 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 written in English.
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 see 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.