The role of IT in the implementation of the EU Medical Device Regulation

When:  Apr 21, 2022 from 17:30 to 19:30 (CET)
Associated with  Malta Chapter

We often hear about the various European Union Directives that turn into regulations. But do you really know what that means for companies within the EU?

Rosemary M. Amato, CISA will share her personal experiences with you and present a real life case study of how a company is implementing EU Regulation (EU) 2017/745 on the clinical investigation and sale of medical devices for human use.

Boring subject? Absolutely a big NO. Did you know that the Malta Competent Authority – Malta Medicines Agency – has already approved the registration of 2 Authorised Representatives, 29 Importers and 181 Legal Manufacturers. Amazing!

One of the biggest components required to implement this regulation is a robust IT environment. Many companies have started the multi-year journey, incurring huge costs and involving many people dealing with changes to their processes and technologies.

If you are a CISA, CISM, CGEIT, or CRISC professional, you need to stay current on how EU regulations may impact the companies you work in or serve. And as an ISACA member working with IT, you should have a good understanding of the IT areas in a company that are affected by these new regulations. So come prepared to listen and learn and get your questions ready for Rosemary.



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