EVENT | MedTech Summit

February 13, 2025

We are excited to announce that Asphalion will be attending the MedTech Summit in Budapest on February 26-27, 2025!

Our expert, Fran Rodríguez, will be part of an insightful panel discussion, tackling key challenges in Quality Management Systems (QMS) for MedTech companies, including:

  • Frequent errors and challenges consultants face when assisting manufacturers with QMS documentation.
  • The hurdles of meeting both ISO 13485 and the specific MDR quality requirements.
  • The Increased scrutiny by notified bodies during CE marking audits, emphasizing the need for robust evidence and documentation concerning the implementation of QMS, and its implications for manufacturers.

 

Join us for this insightful discussion and connect with industry leaders to navigate the evolving regulatory landscape.

For event details and registration, please visit: https://medtech.events/

Looking forward to seeing you there! Contact us to schedule a meeting: [email protected]

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NEWS | FAQs on the European Health Data Space

The EHDS Regulation has three main parts, each with different addressees:

Chapter II on primary use provides additional rights to patients and establishes the technical infrastructure necessary for their implementation.

Chapter III on Electronic Health Record (EHR) systems is addressed to manufacturers and other economic operators who make EHR systems available on the market.

Chapter IV on secondary use is addressed to health data holders and users.

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