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This training is designed for people in charge of medical device compliance, including:
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.
Kristina 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).
Live online trainings via webinars are currently delivered in English only. However, we plan to deliver some of the trainings in other languages, too.
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.
You just need your computer with a browser - webinar recordings can be watched as any other video on the internet, e.g. on YouTube.
The number of views is not limited - you can watch the recordings as many times you wish.
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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