🔥 Find me at MedicalDevicesGroup.net 🔥
6 min reading time
“I find many device manufacturers fall short with their documentation,” writes CEO Emanuel Weisgras, who answered my group invitation with expertise to share here.
These five points may help you through regulatory and speed you to market.
1. Have an outside technical writer prepare your Instructions for Use (IFU). The IFU must be written so someone completely unfamiliar with the device can know how to use it. An independent technical writer who picks up the device, learns how to use it, and writes about it is the way to go.
2. Remember American English (for FDA) is different than UK English (for CE Marks). Having both on one submission is just plain sloppy and may introduce confusion and delay.
3. Define your terminology and use it consistently. Doing so will be enormously helpful when you’re translating for different markets. Create a term list and style sheet to ensure your documentation is consistent and professional.
4. Validate your documents for completeness. Submissions and the like go into a bureaucratic vortex. Don’t make it harder for them to get through your work.
5. When translating, exclusively use a provider who:
Thank you, Emanuel. Learn more at http://weistrans.com.
If you read this and thought, “I have something Joe could share in a future announcement,” contact me because:
Email me at [email protected] with suggestions, thanks.
April 29: Startup Pitch tank at World Health Congress in DC. 100 applications considered, 30 pitch: http://bit.ly/WHCC18 Code HPIO2018 saves $100.
Make it a great week.
I’m not sure how best to emphasize: This is Our Group, not Joe’s group. I believe my moderation (filtering out the detritus you surely don’t need) is what keeps the group vibrant and alive.
But I sincerely hope and deeply encourage YOU(!) – yes, you reading this – to consider “what do I know about medical devices that other members likely don’t know,” and share it. As long as it’s not promotional and potentially valuable to the busy medical device executive, you’ll always have a platform here. 👍
Kevin E. Flynn
MANOHARAN GOVINDA PILLAI
Beluh Mabasa Ginting
Valerie J Taylor
Roger S. Reiss
Marked as spam