Discover the course
ONLINE TRAINING: 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.
This online training is divided in 3 modules:
- Module 1 | 11 June 2020 from 11:00 am to 13:00 pm
- Module 2 | 16 June 2020 from 11:00 am to 13:00 pm
- Module 3 | 18 June 2020 from 11:00 am to 13:00 pm
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 540,00* (until 21 May 2020)
Ordinary: € 615,00*
Freelance - Academy - Public Administration**: € 324,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: Access to the online training, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
Thursday, May 21, 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