Course

Medical Device Registration: Strategies to Place your Devices in the EU, UK and US

02 May 2024
Zoom
5 hours
English

16:00-21:00 Brussels
15:00-20:00 UK
10:00am-03:00pm New York

$680 Until 22 Apr 2024

$800 Until 02 May 2024

About the Course

Lecturer: Maria Duguine

I´m Maria Duguine and I hold a BS in Chemistry. I´m Italian, grew up in Buenos Aires Argentina, many years ago I returned to Italy and spent long times between Spain and the United States. Currently I'm living in Barcelona, a place that I love and enjoy with my husband. Although I finished my studies many years ago, I never really stopped studying. I have done different trainings in the United States and Europe, to improve my knowledge in different areas of medical devices. Especially, because I feel that one of the strengths of my work is being up-to-date and knowing the regulations on new technologies. Also, my most recent training has been related to updates in novel medical devices.
I´ve been working in the industry for almost eighteen years, within the area of Regulatory Affairs, for medical devices and novel products. In the beginning I worked in International Pharmaceuticals (Bayer and Novartis) and at one point I joined a big Italian to work as consultant. That job lit my flame! Helped me to have a more global understanding of the needs of different sizes of clients. This, together with my registration as a PRRC to act as Authorized Responsible for medical devices, gave me a strong training in documentation from the point of view of Notified Bodies, which in fact, with some of them I work closely.
As consultant, I have prepared regulatory strategies for different markets, in which the fact of having friends in the industry makes it easier to obtain time and cost information. I have been in charge of drafting Quality Management System procedures to help manufacturers to obtain the ISO 13485 or to comply with the CE mark requirements; I have written Technical documentation for medical devices and invitro diagnostics, as well as Clinical Evaluations and Performance evaluations. Also, I help medical device manufacturers when they are in a difficult position with Notified Bodies, or for preparing the documentation, or just to have a direction to move forward.
In addition to my extensive experience in the medical device sector, I have also ventured into the captivating realm of cosmetics. With a background in chemistry and a keen eye for the finer details, I've delved into the world of cosmetic product regulations and registrations. Over the years, I've engaged in the preparation of regulatory strategies for cosmetics, navigating the intricate web of compliance requirements and product registrations in various markets. My in-depth understanding of regulatory intricacies has enabled me to ensure that cosmetics meet stringent safety and quality standards while adhering to regional and international regulations. My dedication to staying informed about the latest trends and innovations in the cosmetics industry complements my broader regulatory expertise, offering a holistic perspective that is invaluable to both the medical device and cosmetics sectors.
Personally, I feel that for a product to meet expectations, the work must be comprehensive, it includes various areas from engineering to marketing, and I enjoy working dynamically. I´m very passionate about different regulations and regulatory pathways and, I wish to learn much more.

In the rapidly evolving world of medical device regulation, mastering the intricacies of global compliance is crucial for manufacturers, regulatory professionals, and industry stakeholders. Our “Global Medical Device Registration Mastery: Navigating EU, UK, and USA Compliance” course offers a comprehensive and in-depth exploration of the medical device registration process in the European Union (EU), United Kingdom (UK), and the United States (USA).

With a focus on the latest regulatory updates and best practices, this training program is designed to equip participants with the knowledge and skills needed to navigate the complex landscape of medical device registrations in these key markets. From regulatory requirements to submission procedures and post-market surveillance, our course provides a holistic understanding of the entire product lifecycle.

Whether you are a medical device manufacturer seeking to expand your market presence or a regulatory professional aiming to stay updated, this course will empower you with the expertise necessary to ensure compliance, expedite registrations, and bring innovative medical devices to patients worldwide. Join us and embark on a journey toward regulatory excellence in the global medical device industry.