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Free webinar — How to conduct usability engineering under the EU MDR

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
Webinar designed for companies and managers who need to conduct usability engineering for medical devices under the European Union Medical Device Regulation. It shows the basics, key factors, and documents needed to become compliant.

Language: English

Format: Recorded webinar

Duration: 42m 32s

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Register for this webinar to learn:

  • What is usability, and what are the keywords?
  • Why is it necessary to conduct usability engineering?
  • What regulations are applicable?
  • What kind of errors are there while using a medical device?
  • What is formative evaluation?
  • What is summative evaluation?
  • Which documents are necessary?

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 BrkicKristina 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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Live online trainings via webinars are currently delivered in English only. However, we plan to deliver some of the trainings in other languages, too.

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No, all our live online trainings are delivered through Internet only, via webinars. Webinars enable you to experience both audio and video presentation from our presenter/trainer.

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