Regulate This! Writing for the Medical Device Industry
summary
Brainlab documents 800 products and about 300 instruments with a six‑person team totalling 75 years’ experience and an error‑logging workflow; authoring uses Ixiaoft with Oxygen and a CMS that holds translations into ~28 languages and version history. MDR in 2021 forces larger, stricter IFUs so one global document usually suffices but sometimes parallel FDA/MDR variants exist; revision cadence is roughly once a year (patient‑data products 2–3). Outputs include laminated quick reference guides and HTML/PDF masters plus a software bill of materials for cybersecurity tracking.
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chapters (17)
- 0:00Medical device documentation intro
- 2:28Team workflow for docs
- 4:59International market regulations
- 8:34MDR impact on docs
- 12:30Industry standards and compliance
- 13:32Regulatory challenges for instruments
- 17:53Documentation pitfalls
- 18:14Cybersecurity in devices
- 21:04Translation prep for docs
- 26:25Balancing regs and user needs
- 27:49UX beyond manuals
- 30:12Non-compliance risks
- 31:16Evaluating translated docs
- 33:19Quick ref guides exemptions
- 34:21Internal compliance tools
- 36:46Simplifying instructions
- 38:12Q&A
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