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Скачать или смотреть Healthcare Software and the impact of the new Medical Device Regulation in Portugal

  • EIT Health Innovators Community
  • 2021-09-16
  • 60
Healthcare Software and the impact of the new Medical Device Regulation in Portugal
Eithealthregulationmedical deviceshealthcareeuropewebinareit health alumnimedical lawinsurance law​portugalportuguese
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Описание к видео Healthcare Software and the impact of the new Medical Device Regulation in Portugal

📽️[ LANGUAGE - PORTGUESE]​

The new Medical Device Regulation is fully applicable since 26 May 2021, which increases the security and control of medical devices within the European Union. The Medical Device Regulation further clarifies software as a medical device, a classification already covered on the scope of the previous Directive. Being Digital Health a field of focus in Portugal, it is important to understand the impact and preparation of the industry and healthcare professionals to comply with the security and quality requisites for healthcare products, even if they take the shape of digital tools, less common in the past on the clinical practice. 

This webinar aims to introduce industry and clinical audience to the basic concepts of software as a medical device and discuss the readiness of stakeholders to comply with the new requirements during a transition period that may extend, in particular to software manufacturers, until 2024. 

👩‍💼Celia Cruz, Co-founder, Complear Health, Portugal​
👨‍💼Mariana Madureira, Co-Ordinator of Medical Device Sector, Infarmed, Portugal​
Moderator – Miguel Amador​

➡️Let's Talk Regulation Series brings experts from our community together with external speakers to share advice and guidance on how to navigate the Medical Device Regulatory process.

The regulatory process is one of the biggest challenges formed by tech startups, and raises many important questions: Do I have a medical device? How do I even begin the process? This webinar series aims to help you answer these question.


🌐Join our community of Healthcare innovators and,​

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