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Free webinar – How to Construct and Prepare Technical Documentation for Medical Devices Under the EU MDR

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
The purpose of this webinar is to help you understand which set of documents needs to be part of technical documentation to provide evidence of a medical device’s safety and performance. Become familiar with how to construct it according to Annex II and Annex III of the EU MDR

Language: English

Format: Recorded webinar

Duration: 49m 54s

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Register for this webinar to learn about:

  • Regulatory requirements and basic postulates
  • Content of technical documentation
  • Where to start with constructing technical documentation
  • Special attention to pre-clinical documentation
  • Examples of documentation
  • Application to the Notified Body

Target audience:

This training is designed for team members responsible for medical device technical documentation, including:

  • Quality managers
  • Production managers
  • Sales managers
  • Persons 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 as 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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