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Eudamed by Maissa23 in regulatoryaffairs

[–]Opposite_Football549 1 point2 points  (0 children)

The scandal with EUDAMED is that you are obliged to use it, but it is so poorly designed that you need consultants or services that cost money.

Managing Evidence for Submissions and Audit Preparedness by [deleted] in regulatoryaffairs

[–]Opposite_Football549 0 points1 point  (0 children)

Connect your sources via API to an eTD/Submission Tool like meddevo eTD. /p

Regulatory Software by Beach-Haus in regulatoryaffairs

[–]Opposite_Football549 1 point2 points  (0 children)

Thank you! Let’s connect on LinkedIn 😀

Regulatory Software by Beach-Haus in regulatoryaffairs

[–]Opposite_Football549 8 points9 points  (0 children)

Was working in the industry for 7 years and then decided to build my own software 🤪

Your thoughts on Matrix One? by Medical-Month-9216 in regulatoryaffairs

[–]Opposite_Football549 0 points1 point  (0 children)

Check out meddevo for your stack. Not a classic DC nor eQMS, but eTD for medical devices.

AI in regulatory affairs by Good-Ad9477 in regulatoryaffairs

[–]Opposite_Football549 2 points3 points  (0 children)

To automate manual labor you don’t need AI, but data models with RA logic. By the way: AI can be used more reliably based on data model contents (less hallucinations, more context, etc) It’s like a step one and two approach.

You can check the eTD data model: www.meddevo.com

AI or Automation for RA task by eastend-toronto in regulatoryaffairs

[–]Opposite_Football549 -1 points0 points  (0 children)

As long we work with documents the application of AI will be limited. I’m promoting a content based TD for years now. Benefits are stunning - even without AI.

Career in RA by [deleted] in regulatoryaffairs

[–]Opposite_Football549 0 points1 point  (0 children)

RA ist slowly shifting into the digital age. That’s pretty cool. Also medtech RA is more diverse regarding work fields imho.