ISO 13485 Training Courses

ISO 13485 Training Courses

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ISO 13485 represents the medical device industry's quality management system (QMS) standard. It specifies requirements for an organization to design and implement a quality management system able to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Obtaining an ISO 13485 Certification with BSI ensures worldwide recognition for your organization compliance with ISO 13485 requirements. It also represents solid starting point if you are thinking of applying for MDR and IVDR.

Course list

ISO 13485:2016 lead auditor training course (TPECS) >

The course focuses on key principles and practices for effective Quality Management System audits according to ISO 13485:2016 and ISO 19011:2018. Experienced instructors will guide you throughout the audit process, from its management to results reporting. Increase your knowledge and develop additional skills to plan, conduct, report and follow-up a compliant QMS audit.

4 day public classroom

Medical device qualification pathways


Why BSI?

  • Trained 70% of the top 100 medical device companies
  • Medical Device Qualifications
  • Internal expertise
  • Global scale
  • A full scope Notified Body

Not sure what course is right for you?

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