business standards course
Gain mastery over essential business standards for connected medical devices, navigating EU, French, and North African regulations. Develop compliant quality management systems, handle risk management, data protection, and cybersecurity to enhance your business law expertise and client advisory services.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This course delivers a practical overview of ISO 13485, ISO 14971, IEC 62304, GDPR, and vital EU, French, and North African medical device regulations. Discover how to set up a compliant quality management system, oversee suppliers, safeguard cybersecurity and data, and gear up for audits, market entry, post-market monitoring, and incident management with 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, including vigilance, PMCF, and effective recalls.
- Perform compliance gap analyses to map standards, address 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
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