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, handle risk management, data protection, and cybersecurity to enhance your business law practice and client advisory services.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This course delivers a hands-on introduction to ISO 13485, ISO 14971, IEC 62304, GDPR, plus vital EU, French, and North African medical device rules. Master building compliant quality systems, supplier oversight, cybersecurity safeguards, data privacy, audit readiness, market entry strategies, post-market monitoring, and incident response through straightforward, practical guidance.
Elevify advantages
Develop skills
- Apply EU MDR and French regulations for swift, safe device market entry.
- Implement ISO 13485 QMS to create efficient, audit-ready processes quickly.
- Manage medical device cybersecurity with secure design, cloud security, 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 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