Free webinar – A How-to Guide for ISO 13485 Implementation

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
Webinar designed for companies that are planning to implement ISO 13485, and don’t have much experience with the standard. This webinar will help you understand what kind of standard ISO 13485 is, what the basic terms are, and what the implementation process looks like.

Language: English

Format: Recorded webinar

Duration: 62m 14s (1h 2m 14s)


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Register for this webinar to learn:

  • How to understand specific terms in ISO 13485 for non-medical personnel
  • Steps to implement ISO 13485:2016
  • Documentation required by the standard
  • Tips for implementation – using tools, hiring a consultant, costs involved, how long does it take
  • What to expect during the implementation and certification process

Target audience:

This training is designed for those who need to implement ISO 13485, without ever having encountered the notion of medical products before, hence complete beginners, including:

  • Owners of a medical device manufacturing company
  • Top management
  • R&D managers
  • Sales personnel

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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