Expert’s Point of View: validation of a medical solution

Larry is a validation consultant engineer working at the CVO-EUROPE’s Geneva office since 2018. He is now in charge of computerized system validation in medical devices companies.

I was working for a medical devices company which develops, manufactures and distributes innovative connected medical devices.

My mission lasted 10 months and the goal was to validate a new major version of a medical solution in order to deploy it several new countries around the world.

The medical solution allows the users to manage and monitor daily the patient’s growth hormon injections.

The purpose of my mission was to perform the verification and validation acitivities were properly performed in compliance with the functional, non-functional and legal requirements (including MDR 2020, GAMP5, ISO13485, 21 CFR PART 11, ISO 27000-27001).

I was integrated in the VnV team of the company and I was working with 2 internal colleagues on the project.

Their roles were to define the planning of follow up the verification and validation activities.

The solution was divided in to part :

1. A medical device which allow a patient to perform his daily growth hormon injections
2. A connected medical device system made of
   • A web server application used by the health professionals
   • Mobile applications (Android and iOS) used by the patients and their carers

The goals of the system are :

• Allow the health patient carers to
  • consult the patient injection history
  • contact his related health professional
• Allow the health professional
  • Consult patient injection history
  • Modify the patient medical treatment
  • Send reminders alert to the patient to perform his injection

The validation activities were performed in several phases and ensured that the following parts of the system met the expected criteria :

• The Android new hotfix and major builds
• The iOS new hotfix and major builds
• The web server new hotfix and major builds

As the results of these activities, the system has been successfully deployed in more than 10 new countries in Europe, Asia and Canada.