Discover the course
FDA Medical Devices Registration
Different submission types and how to prepare a 510K
One of the most highly sought after goals of any medical device manufacturer is the American market. Both in terms of economical prospect and of obtaining the FDA certificate. Still, the FDA registration of medical devices is often considered an overwhelming obstacle and a corporate effort that risks not being sufficiently rewarding.
This training provides a precise overview of:
- how FDA reviewers face the dossiers received
- what information or level of detail is expected
- and how to deal with reviewers
to make the approval process much faster and more profitable for the whole company.
- FDA Manufacturers registration (Establishment Registration): brief introduction
- Classification of medical devices according to the FDA and related registration process (510K, PMA). Hands-on classification exercises
- UDI: timelines and ways to implement it
- The new FDA guideline: understand the FDA perspective and how to best use it; generate the documentation you need for registration
- 510K: the importance of strategy. Practical examples
- How and why to integrate the FDA strategy in the overall device development process: overlaps and differences as compared to the MDR
- The structure of a 510K, when and how to submit
- How to deal with FDA and how to reply to deficiency letters
- Registering devices that do not require a 510K: PMA and Combination Devices (drug-device & device drug)
The course will be in Italian.
He graduated in Chemistry and Pharmaceutical Technology in 2004. Thereafter, he gained extensive experience in the Regulatory Affairs field in various multinational companies, spanning from cosmetics, to biocides, and food supplements. Since 2007 in particular, he has often worked in the field of medical devices.
Presently helping clients as a freelancer, he actively collaborates with many different international companies and helps these to obtain CE marking in the EU and Market Access in Italy. He is also involved in registration of medical devices in the United States and all around the world.
Regulatory Affairs Specialist/Officer; Regulatory Affairs Manager; Clinical Operations; Medical Writing; CEO / CTO´s working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
This training is designed for those who already have a basic regulatory knowledge of the needed requirements to obtain a CE mark and who wish to broaden their knowhow and learn more about the US market.
Knowledge base training, hands-on exercises, case studies discussion.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 790,00* (until 08 April 2020)
Ordinary: € 905,00*
Freelance - Academy - Public Administration**: € 485,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Wednesday, April 8, 2020
At the end of the training, you will be able to
Classify medical devices according to the FDA and understand how to appropriately register devices in the USA
Collect and organize the needed content and documents to prepare a 510K
Know which guidelines are applicable to the devices you are working with
Correctly plan the strategy for registration and ask the different corporate roles to prepare the needed documents since the very start of product development