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.
💭 The event will feature a mix of formats designed to educate and engage participants, including expert talks, interactive sparring session, 1:1 office hours, open discussions, and networking on topics such as:
Introduction and critical aspects of QMS under MDR/IVDR
Practical Implementation Considerations for QMS (ISO 13485) and Risk Management (ISO 14971)
Technical Documentation and Audit Readiness
📣 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, especially those 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 (Ülemiste City) and online on the Zoom platform.
💺 The seats are limited. The organizer reserves the right to review registrations to ensure the maximum number of relevant participants at the event.
🗓️ The exact agenda and venue will be announced by September 30.
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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 qualify for office hours, a company should be able to demonstrate a TRL level of 4 or higher.
1:1 sessions should focus on validating assumptions and/or seeking expert advice regarding:
Regulatory strategy
Market strategy
Perceived clinical benefit
Risk management
Clinical evaluation
Organizational challenges
Fundraising challenges
Participants should send a brief yet comprehensive summary of their company or project, product(s), claim(s), regulatory pathway, market strategy, and clinical strategy, along with any specific topics or questions they would like to address, as a separate email to [email protected]
Selected startups will receive a separate email confirming their selection and operational details by September 30, based on:
the clarity of their overall summary,
the potential impact the advice will have on the startup,
Matthew’s ability to address the topic.
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.