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This course provides and overview of the Design Control system and process, and highlights the key compliance drivers and regulatory requirements of FDA 21 CFR 820.30.

EU MDR Training

Introduction to Design Control

The Design Control online training module covers a high-level understanding of why the Design Control is important, how it supports your overall business, and where it is an integral part of your overall quality system.   It will also identify the different elements, phases and process for design control, as laid out by FDA 21 CFR 820.30.

Intro to Design Control Course Outcomes:

After taking this training course, learners will be able to:

  • Define key terms used in Design Control
  • Identify the different phases for design control
  • Summarize the regulations for Design Control as laid out by FDA 21 CFR 820.30
  • List the documents required for Design Control

Benefits from taking the PathWise Introduction to Design Control course include:

  • Identify all required phases, processes, and documents as laid out by 21 CFR 821.30
  • Define key terms
  • Optimize training time, through self led online modulesF
  • Fulfill FDA Learning Requirements, and ensure employees are receiving consistent training across the organization

Introduction to Design Control online training is for those individuals involved in the design, production, auditing, installation and servicing of medical devices.

The Introduction to Design Control online training module is worth 0.1 CEU credits.

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.

Learners must complete the following in order to earn CEU credit:

  • Verify your electronic signature
  • Complete the full course introduction module on ePath
  • Complete the full instruction module
  • Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment). 

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