business standards course
Master essential business standards for connected medical devices under EU French and North African regulations. Develop compliant quality systems manage risks data protection and cybersecurity to enhance your business law practice and client guidance. This course equips you with practical skills for audits supplier management and market access ensuring robust compliance and operational success.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Gain a practical overview of ISO 13485 ISO 14971 IEC 62304 GDPR and major EU French North African medical device regulations. Master implementing compliant quality management systems supplier oversight cybersecurity data protection audit preparation market access post-market surveillance and incident management through clear actionable guidance.
Elevify advantages
Develop skills
- Apply EU MDR and French rules for quick safe market access for devices.
- Implement ISO 13485 QMS to build lean audit-ready processes in weeks.
- Manage device cybersecurity with secure design cloud controls and GDPR basics.
- Run post-market surveillance handling vigilance PMCF and recalls effectively.
- Perform compliance gap analyses mapping standards fixing risks and documenting proof.
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
As suas aulas são perfeitas. Adquiri o pacote de um ano e, finalmente, tenho a oportunidade de acompanhar diversos temas do meu interesse sem precisar mudar de plataforma... agradeço por tudo o que fazem, já recomendei vocês a outras pessoas...

Giulio CarloAluno de Marketing Digital
Eu gosto de como as lições são direto ao ponto e como eu consigo alterar capítulos e pular conteúdos que não preciso.

Mariana FerresAluna de Fotografia
Gosto do conteúdo e do modo de apresentação e transcrição de vídeos, o que acelera o processo!

Luciana AlvarengaAluna de Design de Unhas
A plataforma é rápida, simples de usar. A diversidade de conteúdo e os vídeos complementares ajudam muito no aprendizado.

Giulio CarloAluno de Engenharia de Prompt
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