2024-10-14 2024-10-14 , online online, 1,090 € plus tax Christoph Kiesselbach https://www.forum-institut.com/seminar/24112515-global-medical-device-registration-usa-canada-and-latam/referenten/24/24_11/24112515-global-medical-device-registration_kiesselbach-christoph.jpg Global Medical Device Registration: USA, Canada and LATAM

This webcast series is tailored for those seeking to understand market access for medical devices and technology in North and South America through concise, focused sessions, with the added benefit of addressing your specific questions.

Topics
  • Comparison of country-specific regulatory requirements with those of the EU
  • Detailed overview of approval procedures and pathways
  • Insights into the challenges of market access
  • Updates on global audits: Medical Device Single Audit Program (MDSAP)


Who should attend
The webcast series is designed for specialists and managers at international medical device companies seeking to enhance and update their knowledge of regulatory affairs.

It is particularly relevant for professionals working in the following departments:
  • Regulatory Affairs
  • Quality Management
  • Clinical Affairs
  • Operations Management
  • Business Development

Prerequisite: A basic understanding of medical device certification within the EU.
Aims and objectives
This webcast series consists of four live sessions focusing on the diverse regulatory requirements and approval processes for medical devices in North and South America.

Each live webcast lasts between 1.5 and 2 hours. Join online and take the opportunity to ask questions at any time.

Presentation materials will be available for download beforehand, and you will receive a certificate of completion upon successfully completing a learning assessment.

What if you miss a live session? No problem! A recording of each webcast will be accessible online after the live broadcast.
Your benefit

  • Gain in-depth knowledge of the specific regulatory requirements and approval processes for effective, compliant product registration across international markets.
  • Understand the differences in registration procedures between the EU and other regions to optimise your global strategies.
  • Minimise compliance risks by staying informed about market access challenges and regulatory hurdles.
  • Prepare for regulatory audits with insights into the Medical Device Single Audit Program (MDSAP).

24112515 Global Medical Device Registration

Global Medical Device Registration: USA, Canada & LATAM

Interactive Webcast Series Live and On-Demand

Benefits
  • Concise overview of international product registration
  • Short learning modules, ideal for busy workdays
  • Recordings of the live session
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24112515

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

26/11/-11/02/2025

26/11/-11/02/2025

Period

Please refer to the program on our website for dates and times.

Please refer to the program on our website for dates and times.
Venue

online

online

Fee
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

This webcast series is tailored for those seeking to understand market access for medical devices and technology in North and South America through concise, focused sessions, with the added benefit of addressing your specific questions.

Topics

  • Comparison of country-specific regulatory requirements with those of the EU
  • Detailed overview of approval procedures and pathways
  • Insights into the challenges of market access
  • Updates on global audits: Medical Device Single Audit Program (MDSAP)


Who should attend
The webcast series is designed for specialists and managers at international medical device companies seeking to enhance and update their knowledge of regulatory affairs.

It is particularly relevant for professionals working in the following departments:
  • Regulatory Affairs
  • Quality Management
  • Clinical Affairs
  • Operations Management
  • Business Development

Prerequisite: A basic understanding of medical device certification within the EU.

Aims and objectives

This webcast series consists of four live sessions focusing on the diverse regulatory requirements and approval processes for medical devices in North and South America.

Each live webcast lasts between 1.5 and 2 hours. Join online and take the opportunity to ask questions at any time.

Presentation materials will be available for download beforehand, and you will receive a certificate of completion upon successfully completing a learning assessment.

What if you miss a live session? No problem! A recording of each webcast will be accessible online after the live broadcast.

Your benefit

  • Gain in-depth knowledge of the specific regulatory requirements and approval processes for effective, compliant product registration across international markets.
  • Understand the differences in registration procedures between the EU and other regions to optimise your global strategies.
  • Minimise compliance risks by staying informed about market access challenges and regulatory hurdles.
  • Prepare for regulatory audits with insights into the Medical Device Single Audit Program (MDSAP).

Detailed programme

Please refer to the program on our website for dates and times.

Christoph Kiesselbach

26.11.2024; 09:00 AM - 11:00 AM USA
  • Market access for medical devices: USA vs EU
  • Classification and selection of the right procedure
  • Access procedure: listing, 510(k), PMA, De Novo
  • Preparation, documentation and interaction with the FDA
  • Supplementary topics: quality management, registration, UDI
  • Maintenance: monitoring, changes
  • Current issues

Gabriela Munoz

28.01.2025; 11:00 AM - 01:00 PM Brazil
  • General overview of current admission requirements for Brazil
  • ANVISA: approval procedures and main pathways
  • Differences from the current European approval procedure and where to rely on the MDR
  • Market access challenges

Gabriela Munoz

28.01.2025; 02:00 PM - 04:00 PM Mexico and ROLA
  • Overview of current country-specific admission requirements
  • COFEPRIS: approval procedures and main pathways
  • Comparison with European approval processes: Key differences and reliance on the MDR
  • Market access challenges

Dr. Stefan Menzl

11.02.2025; 09:00 AM - 11:00 AM Canada and the MDSAP
  • Market access for medical devices in Canada
  • The process
  • Comparison with Europe
  • QMS requirements and the MDSAP
  • Basics of the MDSAP
  • Preparation for the MDSAP audit (tips & tricks)

Workshops

In-House Seminar on Medical Device Approval Process: Tailored to Your Needs!

Are you interested in a customized in-house seminar focused on the medical device approval process in a specific country? We can offer a session tailored to your team's needs, providing valuable insights and guidance on navigating the regulatory landscape. Please let us know if you would like to arrange a seminar or if you have any specific questions: v.planitz@forum-institut.de

Your benefits

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

Your benefits

  • Engage Directly with our Experts
  • Receive a Learning Assessment and a FORUM Certificate as Proof of Qualification After the Final Webcast
  • Can't Join Live? Access Recorded Webcasts in a Secure Space at Your Convenience!

This distinguishes our events

of 5 stars of all ratings from 2023

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality