Meet The Experts France: the pathway to certification

Meet The Experts France: the pathway to certification

Don't miss our in-person Meet the Experts Event in Paris.

33 followers
By BSI Medical Devices
33 followers
2 years on Eventbrite 📈

Date and time

Thu, 5 Jun 2025 09:00 - 17:00 CEST

Location

MAISON.A VERSO by Victoire

52 Rue de la Victoire 75009 Paris France

Refund Policy

Refunds up to 7 days before event

Agenda

9:00 AM - 9:30 AM

Welcome

9:30 AM - 9:45 AM

Opening session

9:45 AM - 11:00 AM

Common pitfalls in the technical documentation & common gaps in Risk analysis

Lena Gourmelon

Marion Soubelet

11:15 AM - 11:45 AM

Clinical requirements: PMS & PMCF

Richard Holborow

11:45 AM - 12:15 PM

Structured Dialogue: an opportunity for manufacturers

Richard Holborow

12:15 PM - 12:45 PM

Q&A

12:45 PM - 2:00 PM

LUNCH

2:00 PM - 3:00 PM

Workshop for Start-ups

Geoffrey Pisapia


ISO 13485 requirements & What a client will receive in Stage 1 and Stage 2 audits

3:15 PM - 4:15 PM

Workshop SaMD

Simon Lidgate


Clinical evaluation for software devices, how to manage changes in software

About this event

  • Event lasts 8 hours

BSI is waiting for you at Meet the Experts live event

Once again, this year, our experts are coming to Paris for the annual Meet the Experts event fully dedicated to the EU MDR.

A new opportunity to meet and interact in person with our experts, to explore different aspects of the Medical Device Regulation, to learn more about most diffused pitfalls in complying with regulatory requirements and to be better prepared in facing possible challenges to place your medical device on the EU market.

If you are a medical device manufacturer looking to enter the EU market, at this event you will find the expertise, reliability and transparency of a full-scope Notified Body pivotal for increase your awareness on the compliance journey ahead of you.

What will you gain?

  • Awareness of common pitfalls in technical documentation and gaps in risk analysis / management
  • An understanding of clinical requirements: PMS & PMCF
  • Better understanding of Structured Dialogue with BSI and how it increases the efficiency and predictability of the compliance journey
  • ISO 13485 requirements and and audit
  • Software as Medical Device
  • The opportunity to engage with BSI experts and industry peers

You can book a 1-to-1 meeting with a representative of our team

Up to 2 participants per company will be admitted to the event to allow diversified companies to participate and engage.

Organised by

33 followers
2 years on Eventbrite
€75 – €100