Discover the course

ONLINE TRAINING: FDA Medical Devices Registration

Different submission types and how to prepare a 510K

Date

11-16-18 June 2020

Location

Online

Language

Italian

ONLINE TRAINING: 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.

Online Training

ONLINE TRAINING

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.

Certificate of attendance

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.


Register now

Course Price

615.00 €

Early Bird

Thursday, May 21, 2020

540.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules (2 hours each)

Course Type

Limited number of participants

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

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

The limited number of participants allows a better interaction with the teachers, who can answer all the questions

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ONLINE TRAINING: 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

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@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 (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free 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, to change its performance from residential to webinar/online. 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, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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