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
FAQs
Who is Elevify? How does it work?
Do the courses have certificates?
Are the courses free?
What is the course workload?
What are the courses like?
How do the courses work?
What is the duration of the courses?
What is the cost or price of the courses?
What is an EAD or online course and how does it work?
PDF Course