business standards course
Gain expertise in essential business standards for connected medical devices under EU, French, and North African regulations. Develop compliant quality management systems, risk management, data protection, and cybersecurity skills to enhance business law practices and client advisory services. This course equips you with practical tools for audits, supplier management, and market readiness.

from 4 to 360h flexible workload
certificate valid in your country
What will I learn?
Explore 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, audit preparation, market entry, post-market monitoring, and incident response through straightforward, practical guidance.
Elevify advantages
Develop skills
- Apply EU MDR and French regulations for swift, safe medical device market access.
- Implement ISO 13485 QMS to establish efficient, audit-ready processes quickly.
- Manage medical device cybersecurity with secure design, cloud controls, and GDPR compliance.
- Conduct post-market surveillance effectively, including vigilance, PMCF, and recalls.
- Perform compliance gap analyses to identify standards, mitigate risks, and document evidence.
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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