EU agreement on new medical device rules as Switzerland "Sharpens the Skills!"
On 25 May 2016, the same day as the EU agreed new rules on medical devices and in vitro diagnostic medical devices, the seminar "Medical Device Development - Sharpen your Skills!" was held at the sold-out event venue Marriott Courtyard in Zürich.
The theme of the seminar "Medical Device Development in a dynamic regulatory landscape" was scrutinized in depth by Mario Gennari, Gemar SRL, former TüV auditor and special-guest brought in by the Prismond Group, who stressed the importance of undertaking a combined, timely gap analysis of the new EU regulations as well as the updated ISO 13485:2016 in order to understand, plan and execute the necessary step to comply to the new regulatory requirements. The talk was followed by a lively discussion on how to best solve practical issues entailing these regulatory changes.
Mr. Christian Steiner, from Thoratec Switzerland GmbH shared insights and lessons learned from a recent risk management audit, how to deal with potential findings, and elaborated on best practices when undertaking risk management improvements while optimizing limited resources.
Finally, the Aligned Team presented an analysis on medical device documentation aspects, the drivers behind excessive documentation work and possible solutions around it, concluding that large potential improvements can be made through tight collaboration and feedback between the party that design processes and templates and the party being required to use and fill these artefacts with content.
If you are interested in the presentations, please
We are looking forward to see you at the next seminar!