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New CRDI Open Badges awarded for EU Regulation of Medical Devices course completion

Following up the recent award of Open Badges to those who successfully completed the first delivery for CÚRAM researchers of the online CRDI / CÚRAM Partnership initiative Fundamentals in Medical Device Design and Regulation,  CRDI developed another of these digital credentials for the completion of the online course ‘EU Regulation of Medical Devices’ (further details on the course here). Open Badges are provided as a measure of CPD attainment.

What is an Open Badge?

Open Badges are verifiable, portable digital badges with embedded metadata about skills and achievements. They comply with the Open Badges Specification and are shareable across the web (Social Media, e-Portfolio, Blogs or Online CVs).

 

Sample below of data embedded in the CRDI EURMD Badge

Badge NameEU Regulation of Medical Devices (EURMD) 2018
DescriptionThis badge is awarded to those who have satisfactorily completed the EU Regulation of Medical Devices course offered by CRDI, in partnership with CÚRAM, Centre for Research in Medical Devices. The course is delivered online.
CriteriaThe badge-holder has demonstrated that they have met the key learning outcomes of this course:

  • Understand the legislative framework for medical device regulation in the EU.
  • Be able to explain the purpose and process of CE marking and conformity assessment.
  • Define and explain the importance of clinical data, clinical evaluation and investigation, as well as post market surveillance and vigilance reporting requirements for market approval.
  • Be capable of outlining the basis for the EU Medical Device Regulatory Framework revision; explain the key changes involved and their potential for impact on the device development process.
EvidenceThe holder has demonstrated successful attainment through assessment of the module content by a recognised Manager or Lecturer.
Assessment included online MCQ examination and participation in an interactive problem solving workshops.

 

CRDI is committed to further develop Open Badges in order to reward attendees who successfully complete the assessments of the widely-available CRDI continuing professional development opportunities, and acknowledge instructor contributions to said training. https://www.crdi.ie/education/courses/