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Navigating the Complexities of Medical Device Information with MadCap Software

photo of Solena Le Moigne, Content Architect, , Elegance in Chaos

Presented By:

Solena Le Moigne | Content Architect, Elegance in Chaos

Duration: 60 minutes

Webinar Summary

Join us for an enlightening journey through the intricate landscape of medical device documentation and discover how MadCap Software's suite of HATs (Help Authoring Tools) rises to meet the industry's unique challenges.

 We'll embark on our exploration by delving into the critical need for manufacturers to demonstrate their competence, the efficacy of their processes, and the reliability of their partners and providers. Whether you're new to the field or a seasoned expert, we'll demystify the categories of medical devices, outline the journey from conception to clinical use, and discuss the importance of voluntary compliance with industry standards.

As we consider the broader implications of successful medical devices or the integration challenges posed by corporate mergers, we'll reveal how MadCap Software solutions empower departmental autonomy in information management while fostering interdepartmental collaboration to satisfy QARA regulations.

 This webinar isn't just a presentation; it's an invitation to challenge the status quo, to question and refine your understanding, and to equip yourself with the knowledge and tools necessary for excellence in medical device documentation.

Secure your spot now and be part of the conversation that's shaping the future of medical device information management with MadCap Software and Elegance In Chaos.

 Key Highlights:

  • An introduction to ISO 13485 and its significance in establishing a Quality Management System.
  • A look into how MadCap Flare not only helps to meet validation requirements but also enhances coherence and traceability in documentation.
  • Insights into the necessity of robust document creation processes.
  • Strategies for leveraging a single repository to generate diverse file formats essential for regulatory compliance, such as MDR and IMDRF.
  • Techniques for managing translations effectively to fulfil legal obligations.
  • Approaches to versioning and traceability – can a CCMS streamline the process?

Secure your spot now and be part of the conversation that's shaping the future of medical device information management with MadCap Software and Elegance In Chaos.

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Meet the Presenters

photo of Solena Le Moigne, Content Architect, Elegance in Chaos

about the Presenter

Solena Le Moigne

Content Architect

Elegance in Chaos

With 20+ years professional experience in technical communication, user experience and content strategy, she's worked for fascinating industries such as medical devices, defence, content access and printing. She's now looking forward to sharing experience, insights and professional journey.

Fun facts: Solena is a hobbyist improviser, storyteller, table-top and live-action role playing games player and designer.