Free webinar – Understanding the new European Medical Device Regulation and how ISO 13485 supports it

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
The purpose of the webinar is to familiarize the participants with the basics of the new EU MDR regulation for medical devices, and how ISO 13485 can speed up the compliance process.

Language: English

Format: Recorded webinar

Duration: 57m 17s

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Register for this webinar to learn:

  • What is new in the EU MDR?
  • What are the 5 biggest differences between the MDD and the MDR?
  • New rules of classification for medical devices
  • EU MDR vs. ISO 13485
  • How ISO 13485:2016 supports the new MDR
  • Deadlines for compliance

Target audience:

This training is designed for people in charge of medical device compliance, including:

  • Quality managers
  • Compliance officers
  • Production managers for medical devices
  • Top management
  • R&D managers
  • Quality assurance managers
  • Persons responsible for technical files

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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13485Academy is one of the Academies of Advisera.com. Advisera specializes in helping organizations implement top international standards and frameworks such as EU GDPR, ISO 27001, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO/IEC 17025, AS9100, ISO 20000 and ITIL. Over the years, Advisera has become a global leader in the provision of web-based training and documentation developed by the leading experts.

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