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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
(23)
5
Project
Academic experience
120 hours per learner
Learner
Anywhere
Advanced level

Project scope

Categories
Engineering project management Healthcare
Skills
medical devices quality management systems iso 13485 standard research
Details

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
Deliverables
  • 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
Mentorship
  • Working closely with the director who is supervising and available for questions. This will also include the occasional project progress meetings. Schedule to be determined.
  • We will provide all available information in a timely manner and will be able to hold web conference meetings on a short notice.

About the company

Company
https://pocketclinic.life/
Toronto, Ontario, Canada
2 - 10 employees
Hospital, health, wellness & medical

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.