PRESENTS

HEALTH MATTERS

Leadership & Compliance
in the Medical Device Life Cycle

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1 OCTOBER 2024

NH HOTEL DE LA GARE, BOLOGNA
+ LIVE STREAMING

How can COMPLIANCE shorten the distance between medical devices and the market, ensuring the diffusion of products that truly contribute to the health of men, women and children?

We will discuss this at MDG 2024 | MedGenerAction on October 1, 2024, at the Hotel de la Gare in Bologna and live streaming with leading experts from authorities, organisations, services and the medical industry.

Numerous speeches and points of view for an innovative approach that prepares professionals for the impact of the market by simplifying its complexity.

MDG 2024 – MedGenerAction | HEALTH MATTERS
More than just a conference

  • Speeches by leading experts in the field including Competent Authorities, FDA, Universities, Notified Bodies

  • Debates, information, questions, answers and discussions

  • 9 Device Category-Specific Technical Panel Discussions
  • Simultaneous translation into English and Italian

  • Networking and community exchange

Morning programme: panel discussion and debates
Leadership and Compliance in the Medical Device Life Cycle

with the participation of the European Commission, FDA, Italian Ministry of Health, Universities,
Notified bodies, laboratories, medical service providers

h 08.00 – 09:15
Participant Registration & Networking
h 09:15 – 09.30
Opening Greetings – Massimo Valente (Complife Group CEO), Marisa Testa (Complife Italia Board, Thema CEO)
h 09:30 – 10.10
Round table: Device development between innovation and process management
h 10.10 – 10.30
Questions, answers and discussion
h 10.30 – 11.00
Coffee Break & Networking
h 11.00 – 11.40
Market Access: How Compliance Affects Strategy
h 11.40 – 12.00
Questions, answers and discussion
h 12.00 – 12.40
Maintaining post-market compliance: burden or opportunity?
h 12.40 – 13.00
Questions, answers and discussion
h 13.00 – 14.30
Lunch & Networking

Afternoon programme
Technical Panel Discussions

with the participation of the Italian Ministry of Health, universities, Notified Bodies, laboratories, service providers and the medical industry

A – Active

moderator: Silvia Tamarri

B – Inactive

moderator: Caterina Montesi

C – General

moderator: Flora Hyeraci
h 14.30 – 15.20
Device Usability: Pre-Market Requirements and Application
Using Artificial Intelligence to Demonstrate Biosafety
Using Regulatory Intelligence to Build an Effective Market Access Strategy
h 15.20 – 16.10
Cybersecurity and Data Security
Substance-Based Devices: A Practical Guide on the Application of GSPR 10-4
How to Measure the Impact of Life-Cycle Change
h 16.10 – 16.40
Coffee Break & Networking
h 16.40 – 17.30
How to Evaluate Clinical Effectiveness for SaMD
Reusable Surgical Instruments: Validation and Post-market Follow-up
Inside/Outside Impact of Post-market Surveillance on the Organisation
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Location

Hotel NH Bologna de la Gare

Piazza XX Settembre, 2
40121 Bologna

Participation fees

Take advantage of the EARLY BIRD until July 12

  • 220€ morning
    in-person or live-streaming

  • 380€ full day – in-person only

(excluding VAT)

Reduced Complife/RAPS Italy LNG Group

  • 220€ morning – in-person or live-streaming

  • 380€ full day – in-person only

(excluding VAT)

Full Price Ticket

  • 310€ morning – in-person or live-streaming
  • 540€ full day – in-person only
(excluding VAT)

Sign up now!

Sign up now to secure your front-row seat at the most relevant event in the medical device industry!
all’evento più rilevante del settore dei dispositivi medici!

    Select your method of participation*


    BES (Special Educational Needs) Learner*

    Light Lunch Reservation (agreed price 40€, VAT not included)*