69 results

Digital

Posted on 31.03.2022

How strong data protection can help drive digital health

It’s hard to think of information that feels more personal than data about our own health. Yet we’re generating and monitoring more health data now than ever before. From specific technology designed to help manage certain medical conditions to home monitoring tools, there are more and more digital options to help manage patient health. The […]

By Boris Arendt Data Protection Officer at Biotronik

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Global

Posted on 22.11.2021

AMR action plans – what are we missing?

The recent pandemic has bluntly exposed some of the gaps in our healthcare systems across Europe and one thing stuck with me the most: we were not prepared. In many ways, we can think of this as a test run of how the world responds to large-scale healthcare crises. There are more complex threats ahead, […]

By Johanna Engelage Team Leader of Marketing Urinalysis at Sysmex Europe GmbH

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Ethics

Posted on 01.07.2021

Ethical collaborations: new guidelines help companies partner with patient organisations

One of the strongest trends I have observed in healthcare over the past decade has been the growth of patient power. Patients are actively shaping their care like never before. In response, health systems and companies are increasingly focused on the outcomes and experiences that matter to patients. The voice of patients is also becoming […]

By Clarisse Aillet Medical Education Consultant

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Regulation

Posted on 26.05.2021

MDR enters into full application and challenges remain

After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants […]

By Bassil Akra CEO - QUNIQUE GmbH

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Ethics

Posted on 25.03.2021

New training video boosts global compliance – and public confidence

Bringing innovative medical technology to patients around the world is a priority for the medtech industry. This task often relies on a wide network of third-party intermediaries and distributors. While third parties provide valuable local knowledge, logistics and skills, it is important to appreciate that everyone working on behalf of medtech companies is bound by […]

By Aline Lautenberg General Counsel and Director General Legal & Compliance, MedTech Europe

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Value

Posted on 17.03.2021

MedTech Slovenia: building the future together

  The next chapter in the story of Slovenia’s medical technology industry has begun – and it is being co-written by leaders from the in-vitro diagnostics and medical devices sectors. SIEDMA and SLO-MED have formally merged to become MedTech Slovenia. Together, we are combining our expertise to speak for our diverse industry with one voice. […]

By Peter Bratusek President, MedTech Slovenija

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Value

Posted on 17.09.2020

Digital surgical checklists: unlocking the secret to enhanced health worker safety

We all know that working in stressful environments makes health workers more prone to medical errors which can lead to patient harm. The COVID-19 pandemic has revealed the risks health workers are facing including emotional disturbances, healthcare-associated infections, illness and even death. As we mark World Patient Safety Day 2020, it is crucial to address health […]

By Goran Ribaric Director, Regional Safety Officer EMEA J&J Medical Devices

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Regulation

Posted on 19.08.2019

The increased role of Clinical Research Organizations in the context of the new EU regulations on medical devices

In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled […]

By Șerban Marius Roșu Associate Professor of Medicine and Pharmacy, University of Timişoara

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Regulation

Posted on 05.07.2019

Are you ready for Eudamed?

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon […]

By Lionel Tussau Director Business Development, Atrify