Free webinar – Biocompatibility According to the MDR - Where to Start

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
Biocompatibility is critical for medical device manufacturers because it ensures that a device can safely interact with human tissues, cells, and bodily fluids without causing adverse effects such as toxicity, allergic reactions, or inflammation. Becoming familiar with crucial steps in the biocompatibility process and how to prepare a testing strategy for medical devices under the MDR is of utmost importance.

Language: English

Format: Recorded webinar

Duration: 41m 47s

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Register for this webinar to learn:

  • What biocompatibility is, and why it is important
  • Which regulation is important to determine the biocompatibility of your product
  • Why risk assessment is important in determining biocompatibility tests and testing strategy
  • Which documentation for biocompatibility is necessary to be in compliance with the MDR

Target audience:

This training is designed for anyone involved in the preparation of technical files for medical devices, including:

  • Quality managers
  • Persons responsible for preparing the technical documentation for a medical device
  • Design and development managers
  • Company owners

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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