Making the Best of a Bad Situation: Navigating Medical Device Regulations
- Presentation
- Navigating Regulatory Landscapes
- 12. March
- 14:40 - 15:20 PM (CET)
- Meeting Room 4+5
-
Kathryn Reeb
- Brainlab
Contents
When regulations rule your content, user experience is bound to suffer. It doesn't have to be this way! The medical device industry requires the highest of safety standards and is heavily regulated. From regional limitations to balancing multiple regulatory drafts, the authoring and document lifecycle management can feel like a puzzle with too many pieces. This presentation introduces the challenges and limitations that Technical Writing teams have to overcome in order to provide meaningful Instructions for Use in highly regulated industries. We will cover keeping up a sleek and modern appearence to your documents, making the most of eIFUs, what to do if you are called into an audit, how close collaborations within your company can foster long-term knowledge growth and further tips on not only surviving, but thriving in a tough regulated industry.
Takeaways
You will learn how to keep user experience in focus, while meeting strict regulatory requirements, as well as learn from 15+ years of personal experience growing as a technical communicator and becoming a regulatory expert and team lead.
Prior knowledge
None required