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, data protection, and cybersecurity to enhance your business law expertise and client advisory services. This course equips you with practical knowledge for regulatory compliance and market success.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This Business Standards Course offers a practical overview of ISO 13485, ISO 14971, IEC 62304, GDPR, and vital EU, French, and North African medical device regulations. Discover how to establish a compliant quality management system, oversee suppliers, safeguard cybersecurity and data, and ready yourself for audits, market entry, post-market surveillance, and incident management using straightforward, actionable guidance.
Elevify advantages
Develop skills
- Apply EU MDR and French regulations to expedite safe market access for medical devices.
- Implement ISO 13485 QMS to establish efficient, audit-ready processes swiftly.
- Manage medical device cybersecurity through secure design, cloud controls, and GDPR fundamentals.
- Conduct post-market surveillance effectively, covering vigilance, PMCF, and recalls.
- Perform compliance gap analyses by mapping standards, addressing risks, and documenting 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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