ISO 13485: Online Training

Issued by PathWise

Learners define key terms used in quality management systems for medical devices and identify mandatory documentation for ISO 13485. They can describe topics to be covered during management review meetings. Learners can classify required resources for product conformity, and summarize the product realization process. Learners know the importance of internal audits, and can label sources of non-conformances and improvement.

Type Learning
Level Foundational
Time Hours
Cost Paid

Additional Details

Skills

Earning Criteria

Online self led module of training content followed by a test. Learners must pass post course assessment with 80% or higher.

Standards

IACET

PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.