Program Description

Medical Device Monitor Certificate

Estimated Learning Duration of the Program:
6-9 months
Program Description:

This program provides monitor trainees with the necessary information, requirements, and guidelines to become an efficient and compliant clinical research associate in a global industry. Learners will gradually acquire the fundamental processes, regulations, and techniques for performing successful medical device clinical investigations quickly, efficiently, and thoroughly.

The courses in this program include practical skills and tools to successfully accomplish medical device monitoring activities in compliance with good clinical practices in accordance with ISO 14155, 21 CFR 812, and Japanese clinical practices.

This program includes the following material:

  • Interactive multi-scenario case studies
  • Glossary items
  • Detailed charts, models, and graphics
  • Audio and video presentations 

Alternative programs:

Learners interested in this program may also consider WMDO’s CMDA (Certified Medical Device Associate) Clinical Evaluation program, which includes a live exam and CMDA diploma.

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Apply good clinical practice requirements to clinical investigations according to ISO 14155, 21 CFR 812, 50, and 56, and the Japanese ICH for medical devices
  • Detect problematic situations and non-compliances early on
  • Find solutions efficiently and implement corrective actions
  • Develop successful work processes
  • Think in a “continuously improving” mode
  • Achieve the proper communication skills to work effectively with site personnel and other players during clinical investigations
  • Optimize writing skills for reports

Price:€ 1,119.00

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