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

flexible workload from 4 to 360h
valid certificate in your country
What will I learn?
Explore practical insights into ISO 13485, ISO 14971, IEC 62304, GDPR, plus EU, French, and North African medical device regulations. Master building compliant quality systems, supplier oversight, cybersecurity, data safeguards, audits, market entry, post-market monitoring, 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 fixing risks.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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