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Free webinar - Post-Market Surveillance System According to the EU MDR Requirements

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
The purpose of this webinar is to help you meet the key requirements of your company’s post-market surveillance (PMS) under the EU MDR 2017/745 and explain how to integrate them with the QMS.

Language: English

Format: Recorded webinar

Duration: 55m 56s

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Register for this webinar to learn:

  • How the PMS system works
  • What regulating requirements are
  • Which documentation you need for integrating PMS requirements with the QMS
  • How PMS, risk management, and clinical evaluation are related

Target audience:

This training is designed for people at medical device manufacturers who are involved in post-market surveillance, including:

  • quality managers
  • production managers
  • sales managers
  • person responsible for regulatory requirements
  • CEOs
  • owners
  • complaint managers

Presented by: Kristina Zvonar Brkic

Kristina Zvonar Brkic

Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and the EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and an auditor and assessor for MDD.

The portfolio of medical devices for which she has approval includes plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, dental materials, different catheters, panels for operating rooms and clean rooms, accessories, kits for performing surgical procedures of non-woven materials, and medical gases.

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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 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.

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