VenueCyberview Resort & Spa
Date24 – 25 October 2024
Summary:
The event themed “Enhancing Compliance and Efficiency in Medical Device Certification,” organized by the MDA CAB Registration Unit (CABRU) and attended by representatives from CAB and industry associations, aimed to refine feedback on key outcomes from the previous MDA-CAB Workshop, Series I. Participants engaged in six working groups focused on GDPMD Report Template, Certification Turnaround Time, Checklist for Medical Gas System Processes, Verification Report Template, Full Assessment Report Template, and Checklist for Clinical Evaluation Processes. The refined feedback from these discussions will be utilized by the MDA to assist in the development of guidance documents related to the conformity assessment process.
Key Highlights:
- Theme: Enhancing Compliance and Efficiency in Medical Device Certification.
- Organized by MDA CAB registration unit (CABRU), participated by CAB & industry association representative.
- The objective is to refine feedbacks on key outcomes from previous workshops (MDA-CAB Workshop, Series I).
- The event was divided into 6 working groups, each focusing on the following topics: GDPMD Report Template, Cerfication Turnaround Time, Checklist for Medical Gas System Process, Verification Report Template, Full Assessment Report Template, Checklist for Clinical Evaluation Process.
- The refined feedbacks gathered during the workshop will be considered by MDA to aid in the development of guidance docs pertaining to the conformity assessment process.
