Free webinar – Understanding the new European Medical Device Regulation and how ISO 13485 supports it

Presenter (in English): Kristina Zvonar Brkic

Kristina Zvonar Brkic
The purpose of the webinar is to familiarize the participants with the basics of the new EU MDR regulation for medical devices, and how ISO 13485 can speed up the compliance process.

Upcoming Dates/Times:

Wednesday – September 30, 2020

11:00 AM Los Angeles time

2:00 PM (14:00) New York time

7:00 PM (19:00) London time

8:00 PM (20:00) Brussels time

11:30 PM (23:30) Mumbai time

Duration: 1 hour / Convert to your time zone

Can’t make the date? Watch the recording here.

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Register for this webinar to learn:

  • What is new in the EU MDR?
  • What are the 5 biggest differences between the MDD and the MDR?
  • New rules of classification for medical devices
  • EU MDR vs. ISO 13485
  • How ISO 13485:2016 supports the new MDR
  • Deadlines for compliance

What you will receive:

  • Training delivered by Kristina Zvonar Brkic, one of the leading experts for ISO 13485 & EU MDR
  • Download of presentation deck
  • Access to webinar recording

Target audience:

This training is designed for people in charge of medical device compliance, including:

  • Quality managers
  • Compliance officers
  • Production managers for medical devices
  • Top management
  • R&D managers
  • Quality assurance managers
  • Persons responsible for technical files

About the training:

What is EU MDR and how can ISO 13485 help with compliance?This live, interactive online training (via webinar) is designed to enable you to walk away with knowledge on what is new in the EU MDR regulation, what the deadlines are, and how ISO 13485:2016 can help you. This course offers compelling content, a downloadable presentation deck, and live engagement with an expert consultant with whom you can discuss how to resolve your specific implementation issues. You will experience the training right from your desk, eliminating travel costs and minimizing lost time away from your office.

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).

Related Frequently Asked Questions

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.

What do I need to watch the webinars on Demand (recording of live online streaming)?

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, ISO 20000 and ITIL. 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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