A Regulatory Puzzle: Writing for the Medical Device Industry

The world of medical device documentation, particularly for Instructions for Use (IFUs), often feels like a complex puzzle.

Technical writers are constantly balancing tight timelines and the need for user-friendly clarity against the unyielding demands of global markets and shifting regulations.

In this session, Holly Mickelson, Senior Technical Writer at Brainlab, shared her expertise on how regulatory frameworks impact medical device documentation and how writers can transform those challenges into opportunities for clarity and consistency.

Key Highlights from the Session:

• Understanding the impact of regulations: How global standards and notified bodies shape the structure and content of IFUs.
• Balancing compliance with usability: Strategies to make IFUs both legally sound and user-friendly.
• Hidden opportunities: How regulatory hurdles can lead to improved documentation workflows and content quality.
• Actionable takeaways: Practical tips for creating clear, consistent, and compliant IFUs that enhance user trust.

About the Speaker

Holly Mickelson is a Senior Technical Writer at Brainlab SE with nearly eight years of experience. Based in Germany, she brings a diverse background in teaching, content creation, and editing, with a special knack for spotting patterns in documentation to ensure consistency and clarity.