News & Events

Events
25. Juli 2024: Webinar – Risikomanagement so flexibel und interaktiv wie nie – das neue RiskPack Pro für Polarion ALM

25. Juli 2024: Webinar – Risikomanagement so flexibel und interaktiv wie nie – das neue RiskPack Pro für Polarion ALM

Risikomanagement nach ISO 14971 ist die zentrale Disziplin für sichere Medizinprodukte. Wir haben unser etabliertes RiskPack stark erweitert und verbessert und machen Ihnen den Risikomanagementprozess jetzt noch einfacher: Mit unserem neuen, interaktiven RiskPack Pro für Polarion ALM.

Jetzt für das Webinar am 25.7. um 11 Uhr anmelden

In unserem Webinar zeigen wir Ihnen unter anderem, wie Sie mit den innovativen Funktionen…

• durch vordefinierte Task Work Items durch Ihren Risikomanagementprozess geführt werden 
• Ihre Risikomanagementdokumentation aus Work Items redundanzfrei und automatisiert aufbauen
• Risiken in gewohnter tabellarischer Ansicht interaktiv direkt in Polarion editieren und bewerten
• auf einen Blick prüfen, ob für alle identifizierten Gefährdungen die festgelegten Risikokontrollmaßnahmen umgesetzt und erfolgreich verifiziert wurden
• in Polarion eine vorläufige Gefährdungsanalyse (PHA) durchführen und wie Sie diese Ergebnisse im weiteren Risikomanagement nutzen 
• Ihr Risikomamanagement aus verschiedenen Perspektiven auf Vollständigkeit prüfen

Das Webinar dauert ca. 30 Minuten. Selbstverständlich beantwortet unser Team während des Webinars gerne Ihre Fragen im Chat. Wir freuen uns auf Ihre Anmeldung!

Alle Informationen zu unserem neuen RiskPack finden Sie in Kürze auch auf unserer Website. Sie wollen vorher schon Kontakt aufnehmen? Dann schreiben Sie uns gerne eine E‑Mail an info@medsoto.de.

23 – 25 May – MedConf in Munich – use our discount code

23 – 25 May – MedConf in Munich – use our discount code

The 16th MedConf will take place from May 23 to May 25, 2023 in Munich Unterhaching. At the conference with exhibition, medical technology professionals meet every year for lectures and relaxed networking. Medsoto GmbH will also be represented again with an exhibitor stand. Managing director Sven Wittorf will give a keynote speech. Use our discount code MC23_MSSW_10% and save 10 percent on your ticket purchase – currently there is still the Early Bird price, so you save twice! Currently, numerous keynotes as well as coaching sessions are already scheduled, the complete program will be published soon. We look forward to meeting you and hearing what is currently on your mind and how we can support you.

27 April: After Work Polarion Insights – Testing with Polarion

27 April: After Work Polarion Insights – Testing with Polarion

Under the motto „from users for users“, the members of the Polarion SIG meet every two months in the format „After Work Polarion Insights“. The focus is on the exchange of experiences of use cases, questions and proposed solutions – practical, participative and solution-oriented. 

On 27 April, Medsoto Managing Director Sven Wittorf will speak on the topic of „Testing with Polarion“. More detailed information on the topic will be available shortly here and on the website of the PLM User Group.

17 November: Polarion Autumn Conference – online

Are you a user of Polarion ALM? Are you looking for solutions to your problems and are curious to exchange experiences with experts like you? This year’s Polarion Autumn Conference offers you presentations and experience reports from users for users. This year’s conference focuses on „DevOps in adapting, deploying and using Polarion“. 

Further information on registration and agenda can be found here.

From 13:30 – 14:20, Dr Janine Hofmann, QM/RA at BECOM AG and Sven Wittorf, Managing Director of Medsoto GmbH will speak on the topic of „Parallel use of Azure DevOps and Polarion – ensuring end-to-end traceability to test results“: Azure DevOps supports software development and offers all functionalities to fully map testing as well. However, the tool has weaknesses when it comes to exporting test results, especially when human-readable, traceable and long-term archivable documentation has to be generated in a regulated environment. The same applies to tracing the tests to requirements. Polarion ALM has clear advantages in these points, which is why many companies use both tools. In this article we present a project in which a seamless integration of the two tools was implemented up to the synchronisation of test runs and test results. We will first look at how the process requirements were mapped in the respective tools and what this means for the connection of the two tools. Finally, we show the solution that was created and report on the experience we have gained so far in this project.

25. Juli 2024: Webinar – Risikomanagement so flexibel und interaktiv wie nie – das neue RiskPack Pro für Polarion ALM

3 November: Medsoto Webinar – What’s new in Polarion 22 R2?

In October, the second Polarion Major Release 2022 will be released. As always, our team is in the starting blocks to thoroughly check all changes and prepare the most important information for you. Sven Wittorf will show you the most important and helpful improvements of the new Polarion version in a webinar on 3 November 2022 at 11 am.

Sven Wittorf will address the following questions:

  • Which new functions have been added?
  • How are the functions to be assessed from the perspective of regulation in medical technology – do they make compliant work easier or more difficult?
  • Which use cases can be implemented better with the new functions or at all?
  • What needs to be considered when updating to this version?
  • What is the impact on Medsoto’s tools?

The webinar will take place on Thursday, 3 November at 11 am and is free of charge. Of course, our team will answer your questions about the new version in the chat. We look forward to an exciting webinar with you!

20 October: The Digital Red Thread in Quality and Regulatory Affairs Management

At this event, Christian Johner and Andrea Seeck from the Johner Institute and Sven Wittorf from Medsoto GmbH will address the digital red thread in quality and regulatory affairs management for manufacturers of medical technology and products. 

Registration Siemens Life Science Forums.

The focus is on the continuous data flow and the consistency and traceability of information and documents. Christian Johner opens the event with the contribution „Digitalisation and monitoring of standards“ from the Johner Institute. Andrea Seeck picks up the thread and shows how the automated monitoring of regulations helps to ensure compliant products and processes. Sven Wittorf links this digital QM/RA thread with practical experience from R&D in his contribution „Integrating regulatory requirements into the development process“.

Finally, there will be enough time for questions.

Agenda

15:00 – 15:15: Welcome address 15:15 – 15:45: Impulse Talk „Digital transformation of regulatory processes“ – Prof. Dr. Johner 15:45 – 16:15: Industry Talk „Automated monitoring of regulations ensure compliant products and processes“ – Dr. Andrea Seeck, Johner Institute 16:15 – 16:45: TechTalk „Integrating regulatory requirements into the development process“ – Sven Wittorf, Medsoto GmbH 16:45 – 17:00: Discussion & Questions