STREAMED LIVE AT 3:00 PM

Registration is closed. IMPORTANT: 

• To access the webinar you must enter your email. Use the email address where you received our communication. 
• Only participants who have registered will have access trought the streaming registration form.
• At the end, attendees will be able to ask questions to speakers through online chat.

Tweet or follow us on Twitter with hashtag #DigitalHealthMDR

The CataloniaBio & HealthTech Regulatory Affairs Workgroup is holding its eigth Hard Reg Café entitled Regulatory and clinical evaluations in digital health solutions on 1 October, online. With the suport of ACCIÓ.

In this training session you will learn about the main laws, regulations and standards that apply to Medical Device Software (MDSW) and health apps under the new EU Medical Device Regulation (MDR). The session will feature renowned experts who advise global healthtech firms and are members of the European Commission’s Medical Device Coordination Group (MDCG). 

They will also present the guidance on Clinical Evaluation of Medical Device Software launched by the MDCG in March. This document provides important guidance for manufacturers and practical examples of clinical evaluation strategies. Clinical evaluation should be understood as an ongoing process of the quality management system for medical devices and aims to ensure the software designed is safe and performs to expectations.

Welcome by Lluís Chico, managing partner of NEOS Surgery and second vice-president of CataloniaBio & HealthTech.

Speakers:

• Koen Cobbaert, Senior Manager of Quality, Standards and Regulations at Philips
• Zuzanna Kwade, Clinical Evaluation Lead of Dedalus Healthcare 

Closing remarks by Lidia Cánovas, general manager for Regulatory Affairs at Asphalion and CataloniaBioHT board member.

PROGRAMME

Follow us on Twitter with the hashtag #DigitalHealthMDR

For: Chief Operating Officers, regulatory managers, compliance managers, quality managers, and consultants of start-ups and companies focusing on medical devices and digital health services, research institutions and research groups.

Language: English

Registration fees: 

• CataloniaBioHT members: free (first two from each company; third person on must pay full rate).
• Non-members: €50 (VAT not included). You will be invoiced €50/person.

This activity will be streamed live. Access will be activated 5 minutes before the session on the cataloniabioht.org website (only participants who have registered before 5:00 pm on 30 September will have access trought the streaming).

Questions: Ismael Ávila (Project Manager) · ismael.avila@cataloniabioht.org

What is Hard Reg Café?

It is a series of coffee work meetings, held once a quarter, to share concerns regarding regulatory issues, debate topics of interest or bring a prestigious guest in this strategic field for CataloniaBio & HealthTech start-ups and companies.

Previous meetings:

• 1st Hard Reg Café "Briefing Meeting" 
• 2nd Hard Reg Café "Briefing Meeting"
• 3rd Hard Reg Café "FDA, ODD and Expedited pathways"
• 4th Hard Reg Café: "The new EU MDR"
• 5th Hard Reg Café:  "Understanding EUDAMED" 
• 6th Hard Reg Café: "Experiències i procediments d'excepció per a producte sanitari i EPIs en la crisi de la Covid-19"
• 7th Hard Reg Café "Open talk with EU Notified Bodies about the extra transition year to implement MDR"