53 results

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Global

Posted on 19.04.2021

Healthcare’s future starts now

As the old saying goes, making predictions can be difficult – especially about the future. If you need evidence of this, think how you might have answered the question ‘Where do you see yourself in five years’ time?’ if you had been asked in 2016.  But while the pandemic has delivered a harsh lesson in […]

By Stuart Silk Board Member MedTech Europe

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Regulation

Posted on 15.05.2019

A bold new vision for the medical technology community

20 years ago, I’d have called you foolish if you suggested that the world’s largest taxi company would not own any taxis. I’d have called you ill-advised if you suggested that the world’s largest hotelier would not own any hotels. I’d have thought you unwise if you suggested that the world’s largest book store could […]

By Eric Thépaut Senior Vice President and President, EMEA - Boston Scientific

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Regulation

Posted on 13.05.2019

IVDR: an overview of clinical evidence requirements

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]

By David Egbosimba Solutions Delivery Manager - Maetrics

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Ethics

Posted on 13.05.2019

Data Protection: If It ain’t broke, don’t fix it?

On May 25, 2018, the GDPR became effective across the EU, simultaneously resulting in a ‘consistent and homogenous application’ of data protection rules across the Union (per Recital 10 of the Regulation). For data protection professionals at medical technology companies, the clarity brought by the GDPR has meant that resources can be redirected towards ensuring […]

By Peter Blenkinsop Partner - Drinker Biddle & Reath LLP

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Ethics

Posted on 13.05.2019

Building synergies between the business and compliance communities

This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities, the industry is sending a clear message: compliance is part of the business! I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes […]

By Anne-Sophie Bricca Co-chair of MedTech Europe’s working group on Ethical AI, and a Deputy General Counsel at Terumo BCT

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Ethics

Posted on 13.05.2019

Transparency: What’s next for the healthcare industry?

In an era where transparency is expected, the healthcare industry has been at the centre of attention from the public and from authorities. We can see this in how governments around the world – notably the US and France – have developed ‘Sunshine Acts’ to mandate disclosure of industry support for healthcare institutions and professionals. […]

By Pascale Schmidt Compliance Officer EMEA/LATAM & RDI - Roche Diagnostics International

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Ethics

Posted on 13.05.2019

Enhanced transparency in healthcare, a pure win-win situation

Healthcare is a complex system in which many actors and interests play a role. Unfortunately, the representation of some prevails over others, quite often even over patients’ interest, despite the fact that the whole system’s aim is to work for their well-being and safety. In mental health, in particular, industry and healthcare professionals have had […]

By Marcin Rodzinka Project Coordinator - Mental Health Europe

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Regulation

Posted on 13.05.2019

Notified Bodies are becoming a regulatory bottleneck

The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

By Fabien Roy Partner - Hogan Lovells

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Digital

Posted on 13.05.2019

Are you ready to use data for good?

I’ve been working with the health system and data for decades. But when my own child developed diabetes – and I was subsequently diagnosed with the disease myself – the dysfunction of the health data ecosystem came into sharper focus than ever. On the one hand, there is a mountain of data. Citizens (those with […]

By Claus Nielsen Co-founder - Data for Good Foundation