GAP ANALYSIS AGAINST ISO 13485:2016 MEDICAL DEVICE STANDARD

2 DAYS TRAINING

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Introduction:

To review and conduct gap analysis for the reference standard QMS MD 13485:2016 to define the level of Compliance within the Organization.

Learning Objectives:

The team from the respective function / department shall be engaged with the Consultant / Trainer to perform the Gap Analysis guided with structured Checklist to identify gap within the function / department.

HRDC Certificate Of Attendance:

Yes

Target Audience:
  1. QA Manager
  2. Regulatory Compliance Manager
  3. Purchasing Manager
  4. Administration Manager
  5. Operations Manager
  6. Any others who are directly involved in this scope of work.
Methodology:
  1. A structured Gap Analysis Checklist shall be used.

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