Business standards course
Gain expertise in essential business standards for connected medical devices under EU, French, and North African regulations. Develop compliant quality systems, risk management, data protection, and cybersecurity to enhance business law practices and client guidance.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Explore practical insights into ISO 13485, ISO 14971, IEC 62304, GDPR, and vital EU, French, North African medical device rules. Master building compliant quality systems, supplier oversight, cybersecurity, data safeguards, audits, market entry, surveillance, and incident response with straightforward steps.
Elevify advantages
Develop skills
- Apply EU MDR and French regulations for swift safe market access.
- Implement ISO 13485 QMS with lean audit-ready processes quickly.
- Manage medical device cybersecurity including design and GDPR.
- Conduct post-market surveillance handling vigilance and recalls.
- Perform compliance gap analyses mapping standards and risks.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
Your classes are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of my interest without needing to change platforms... I thank you for everything you do, I've already recommended you to other people...

Giulio CarloDigital Marketing Student
I like how the lessons are straight to the point and how I can switch chapters and skip content I don't need.

Mariana FerresPhotography Student
I like the content and the way videos are presented and transcribed, which speeds up the process!

Luciana AlvarengaNail Design Student
The platform is fast, simple to use. The diversity of content and complementary videos really help with learning.

André FelipePrompt Engineering Student
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