Discover the course

FDA Medical Devices Registration

Different submission types and how to prepare a 510K

Date

29 April 2020

Location

Milan

Language

Italian

FDA Medical Devices Registration

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)


Course Language

The course will be in Italian.

Giovanni De Paolini
Giovanni De Paolini Medical Device Regulatory Consultant

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.


Participant experience:

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.

Hotel Melià
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.


Upon Arrival
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.

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.



Training Room

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.



Teaching materials

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.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

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.
Brochure
Certificate of attendance

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.


Register now

Course Price

905.00 €

Early Bird

Wednesday, April 8, 2020

790.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

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

Participants' Feedbacks

Good size of number of partcipants;  interesting agenda with appropriate time allocated for presentations and question and answers 

International and multidisciplinary profile of participants, which enriches the training

Variety of topics covered, which have been adapted to the different needs of the participants

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FDA Medical Devices Registration

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, 
following this link.