business standards course
Gain expertise in essential business standards for connected medical devices, covering 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.

4 to 360 hours of flexible workload
certificate valid in your country
What Will I Learn?
Explore practical insights into ISO 13485, ISO 14971, IEC 62304, GDPR, and major EU, French, North African medical device regulations. Master building compliant quality systems, supplier oversight, cybersecurity, data safeguards, audit readiness, market entry, post-market monitoring, and incident response through straightforward, implementable strategies.
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 cybersecurity for devices with secure design, cloud controls, and GDPR compliance.
- Conduct post-market surveillance including vigilance, PMCF, and effective 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
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