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Free webinar – Overview of the Steps Needed to Comply With EU MDR

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
Webinar designed for organizations that have medical devices that need to be certified according to the EU MDR. This webinar will help you understand the necessary steps that need to be taken, and requirements to be fulfilled, to be fully prepared when the MDR takes full effect (May 2021).

Language: English

Format: Recorded webinar

Duration: 52m 49s


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Register for this webinar to learn:

  • What the MDR is and why it is needed
  • Steps for successful MDR compliance for certified medical devices
  • Deadlines for compliance
  • Exceptions for Class I medical devices (self-declaration)
  • List of documentation to be focused on

Target audience:

This training is designed both for those who already have certified medical devices according to MDD and those who are planning for the first certification according to the MDR, including:

  • CEOs
  • Quality Managers
  • Persons responsible for technical documentation
  • Persons responsible for design and development of medical devices

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).