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Latest articles

  1. US and EU flags on poles alongside each other.

    Clinical Evidence under EU MDR: Leveraging FDA Clinical Data to Streamline EU MDR Compliance

    FDA approval alone is not sufficient for European market access - a theme we explore futher in this article and the accompanying webinar.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  2. An AI-generated image of 3 people in an office in front of a whiteboard with the words 'Medical Device Market Entry Strategy' written above a world map.

    EU MDR & NHS DTAC Cybersecurity Requirements for UK Market Entry

    This guest article from our partner Cyber Alchemy shows you how to build cybersecurity evidence for the EU MDR and NHS DTAC.

    Luke Hill Luke Hill Co-Founder of Cyber Alchemy
  3. An illustration showing a GPS-driven navigation route superimposed upon someone using a laptop.

    Where to Launch First? A MedTech Founder's Regulatory Roadmap to the EU, UK and US

    Cyber Alchemy × Mantra Systems — Episode 1: All three markets operate under different regulatory systems and place different demands on manufacturers.

    Ronghe Xu Ronghe Xu Regulatory Medical Writer & Strategic BD Lead China
  4. A woman uses an inhaler.

    Navigating EU MDR Article 117: A Practical Guide to Drug-Device Combination Product Submissions

    Implementation of the EU MDR 2017/745 has brought significant changes.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  5. NHS CEP logo.

    Mantra Systems becomes an official Programme Partner of the NHS Clinical Entrepreneur Programme

    We're proud to join a this initiative supporting healthcare workers and patients to develop innovative solutions for the NHS.

    Paul Hercock Paul Hercock Chief Executive Officer
  6. Collage art showing a pair of binoculars, an analogy for surveillance.

    How EU MDR Post Market Surveillance differs from FDA post-market expectations

    We compare manufacturer-specific post-market obligations across both regulatory systems.

    Dr Gayle Buchel Dr Gayle Buchel Chief Medical Writer

More articles

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