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Free webinar – A How-to Guide for ISO 13485 Implementation

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
Webinar designed for companies that are planning to implement ISO 13485, and don’t have much experience with the standard. This webinar will help you understand what kind of standard ISO 13485 is, what the basic terms are, and what the implementation process looks like.

Language: English

Format: Recorded webinar

Duration: 62m 14s (1h 2m 14s)

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Register for this webinar to learn:

  • How to understand specific terms in ISO 13485 for non-medical personnel
  • Steps to implement ISO 13485:2016
  • Documentation required by the standard
  • Tips for implementation – using tools, hiring a consultant, costs involved, how long does it take
  • What to expect during the implementation and certification process

Target audience:

This training is designed for those who need to implement ISO 13485, without ever having encountered the notion of medical products before, hence complete beginners, including:

  • Owners of a medical device manufacturing company
  • Top management
  • R&D managers
  • Sales personnel

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 for 7 years, and currently MDR.

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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In which language are the webinars delivered?

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

Are these trainings held in person, at a specific venue?

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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You just need your computer with a browser - webinar recordings can be watched as any other video on the internet, e.g. on YouTube.

How many times can I watch the webinar recordings?

The number of views is not limited - you can watch the recordings as many times you wish.

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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