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ISO 13485 Implementation Plan

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Pocket Clinic Corp.
Pocket Clinic Corp.
Toronto, Ontario, Canada
Amir Omidvar
Amir Omidvar
President
(22)
5
Preferred learners
  • Anywhere
  • Academic experience
Categories
Engineering project management Healthcare
Skills
medical devices quality management systems iso 13485 standard research
Project scope
What is the main goal for this project?

The Objective

Implementation plan to achieve compliance with the ISO 13485:2016 standard (Medical devices — Quality management systems — Requirements for regulatory purposes).

Primary Focus of the Project:

  • Research and determination of the ISO 13485:2016 Compliance Requirements.
  • Gap Analysis and determination of where we need to improve or implement new controls.
  • Prepare documentation Requirements in ISO 13485
What tasks will learners need to complete to achieve the project goal?
  • Research and determination of the ISO 13485:2016 Compliance Requirements.
  • Gap Analysis and determination of where we need to improve or implement new controls.
  • Prepare documentation Requirements in ISO 13485
About the company

Pocket Clinic provides personalized therapy for patients with chronic conditions, disrupting the drug delivery market by combining cost-effective high-tech equipment with daily use gadgets like smartphones and smartwatches.