Free webinar – EU MDR Extra Requirements for Quality Management Systems not Covered in ISO 13485

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
The purpose of this webinar is to help you bring your company’s ISO 13485 Quality Management System into compliance with the MDR requirements for the QMS.

Language: English

Format: Recorded webinar

Duration: 44m 27s

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Register for this webinar to learn:

  • What the additional requirements are
  • How to implement them
  • What documents are needed

Target audience:

This training is designed for managers and personnel who need to align their organization’s ISO 13485 QMS with the EU MDR requirements, including:

  • Persons responsible for regulatory compliance (PRRC)
  • Quality managers
  • Personnel responsible for ISO 13485

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 (now MDR) for seven years.

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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About 13485Academy

 

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 and ISO 20000. Over the years, Advisera has become a global leader in the provision of web-based training and documentation developed by the leading experts.

Our products are of best-in-class quality. With a proven performance record of successful implementations in more than 100 countries, our world-class customer support ensures success. Read more about the 13485Academy here.

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