HFE Regulatory Session II: Quality Management Systems & ISO 13485 Compliance MDR / IVDR devices
📍Join us on October 16 from 10:00 to 13:30 in Tallinn or on Zoom for the second edition of the Health Founders Estonia Regulatory Sessions.
🗓️ 💭 Agenda:
10:00 - 10:15 Arriving, registration, light breakfast, welcome + Start of the live stream! ☕️🥐🎥
10:15 - 10:40 Keynote by Matthew DiFranco: “Introduction and critical aspects of QMS under MDR/IVDR” + Q&A (25 minutes)
10:40 - 11:05 Keynote by Matthew DiFranco: “Practical implementation considerations for QMS (ISO 13485) and Risk Management (ISO 14971)” + Q&A (25 minutes)
11:05 - 11:35 Networking Break with light appetizers 🍉🥪(30 minutes)
11:35 - 12:00 Keynote by Matthew DiFranco: “Technical Documentation and Audit Readiness” + Q&A (25 minutes)
12:05 - 12:40 Sparring Session: Matthew DiFranco and Helena Ije, COO of Better Medicine + Q&A (35 minutes) + End of the live stream. 🎥
12:40 - 13:15 Networking (35 minutes)
Who should register?
📣 This event is perfect for MedTech start-ups and scale-ups aiming for MDR/IVDR certification who:
Need to set up a quality management system (QMS) according to ISO 13485.
Already have a QMS but are still in the process of ISO 13485 certification.
Have ISO 13485 certification, but are looking to make changes/improvements.
Are looking for insights into risk management according to ISO 14971.
We also welcome public sector representatives and ecosystem stakeholders involved in healthcare regulation, certification, or supporting MedTech innovation to register for the event.
🇬🇧 🏡 The event will be held in English and will take place as a hybrid event on-site in Tallinn and online.
💺 The seats are limited. The organizer reserves the right to review registrations to ensure the maximum number of relevant participants at the event.
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🚨1:1 Office Hours with Matthew DiFranco
We are offering up to 8 companies the opportunity for 1:1 individual office hours (25 minutes per company) with Matthew DiFranco.
To register for the 1:1 sessions, please send an email to [email protected], including your TRL level, elevator pitch, and the intended purpose of the device being developed, along with any specific topics or questions you would like to address.
Selected startups will receive a separate email confirming their selection and operational details on an ongoing basis.
The HFE program is funded by the EU through Enterprise Estonia, in collaboration with Startup Estonia, to build a strong, globally competitive health tech ecosystem in Estonia.