News & Events

Webinar
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.

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

26 January: Medsoto Webinar – What can the Medsoto Advanced PDF Exporter do?

Do you repeatedly export documents to make them available externally or to store them? Do you need long-term archiving and want to optimise your export process? In our webinar on 26 January at 11 a.m., Sven Wittorf and Jacqueline Mangler will show you how to save time when exporting documents, create PDF/A exports with just one click and automate the export process.

Click here to register for the webinar

With the Advanced PDF Exporter, our latest extension for Polarion ALM, you can export wiki pages, rich pages, documents and test runs individually or collectively with just one click. Use the Advanced PDF Exporter’s clear UI, choose your own regulation-compliant watermark and decide if and when your exports should be initiated automatically. Medsoto’s Advanced PDF Exporter allows you to export directly in Polarion in PDF/A format, which has been specially developed for long-term archiving.

In our webinar, we will address the following questions, among others:

  • What are the challenges of exporting documents?
  • Which regulatory requirements for long-term archiving does ISO 19005 – 1 demand?
  • How does the Advanced PDF Exporter work and what are the benefits of using it?
  • How can document export be automated with the Advanced PDF Exporter and its Workflow Function

The webinar will take place on 26 January at 11 am and will last approximately 30 minutes. Of course, our team will be available to answer your questions in the chat during the webinar.

We look forward to an exciting webinar with you!

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