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Free webinar – ISO 14971:2019 - How to Conduct Risk Management for Medical Devices

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
The purpose of the webinar is to familiarize the participants with the basics of risk management for medical device manufacturers, and to explain necessary concepts so that participants know how to implement risk management themselves.

Language: English

Format: Recorded webinar

Duration: 57m 48s

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Register for this webinar to learn:

  • Key definitions
  • When to perform risk management
  • Why to perform risk management
  • The steps in the risk management process
  • Criteria for defining risk of a device 3×3
  • Criteria for defining risk of a device 5×5

Target audience:

This training is designed designed for professionals with little or no experience in ISO 14971, including:

  • Quality managers
  • Manufacturers of medical devices
  • Top management
  • R&D managers
  • Quality assurance managers

Presented by: Kristina Zvonar Brkic

Kristina Zvonar BrkicKristina Zvonar Brkic has worked as a consultant and lead auditor for ISO 9001, ISO 13485, and ISO 22716 for more than 10 years, and as an auditor and assessor for medical devices under MDD for 7 years, and currently MDR.

The portfolio of medical devices for which she has approval are as follows: plastic products with measuring function (spoons and syringes for giving antibiotics, cups and bags for urine), various creams and gels, different systems for wound care (vacuum assisted therapy, different types of gauze, viscose and cellulose products, sponges and foams), disinfectants, dental materials, different catheters (infusion, transfusion, and urine), panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, and different dental materials (artificial teeth, filling components, and tips for aspirators).

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