70 results

Are%20you%20ready%20for%20Eudamed2
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

Fotolia_213119758_Subscription_Monthly_M
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

Fotolia_175636818_Subscription_Monthly_M
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

Fotolia_217879923_Subscription_Monthly_M
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

Fotolia_146251672_Subscription_Monthly_M
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

Fotolia_177116458_Subscription_Monthly_M
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

Fotolia_168272476_Subscription_Monthly_M
Ethics

Posted on 09.05.2019

MedTech compliance goes mainstream

By combining the GMTCC with the annual European MedTech Forum, the medtech industry is signalling that compliance is moving centre-stage, writes Nancy Travis, Vice President, International Compliance & Governance, AdvaMed For more than a decade, MedTech Europe and AdvaMed have jointly organised the key event on compliance professionals’ calendars. The Global MedTech Compliance Conference (GMTCC) […]

By Nancy Travis Vice President at AdvaMed

Health data can transform our lives – but must be used wisely
Ethics

Posted on 09.07.2018

Health data can transform our lives – but must be used wisely

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage,How to create and maintain an ethical culture,Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and […]

By Oba Adewunmi Legal Counsel at Verily Life Science

New industry code must safeguard independent medical education
Ethics

Posted on 25.06.2018

New industry code must safeguard independent medical education

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture,Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress […]

By Dr. Maarten Simoons Professor of Cardiology at European Society of Cardiology