88 results
Posted on 11.01.2012
How should the EU regulatory framework change because of the PIP incidents?
Since the French authorities made their announcement just prior to Christmas, the PIP case has generated a large amount of press and political attention. Quite rightly, the main focus is on the women affected and on governments providing the right health advice and appropriate follow-up. As I am writing this posting a couple of days after we released our first statement, I understand that the European Commission is to seek an independent scientific opinion on the human health risks of silicone breast implants.
Posted on 09.08.2011
Facing up to the Social Media Challenge – How Should the Industry Engage with Consumers?
Next week, pharmaceutical, biotechnology and medical device companies will change the way they interact with consumers on Facebook. These changes are occurring, not based on new communications strategies or industry regulations, but because Facebook itself is changing its policies.
Posted on 09.06.2011
Rethinking medical device manuals to save lives and trees
Useful, absent, useless or simply not up to modern communication and information exchange practices, finally I’ve just seen an honest debate on the thorny subject of instructions for use for medical devices. It seems that the seeds are being sown in the garden of England for future change to the benefit of everyone.
eHealth applications and websites developed by clinicians: there are rules for that!
eHealth is booming, hospitals, doctors, clinics, SMEs, big companies, everybody seems to be developing an app nowadays. It is great to see how many people are throwing their weight behind eHealth initiatives in every possible way: remote monitoring of demented senior citizens by means of image interpreting software, decision support systems, …, you name it. […]
Posted on 04.05.2011
How we in the U.S. see global compliance challenges for MedTech companies
AdvaMed and Eucomed are co-organizing the upcoming International Medical Device Industry Compliance Conference, taking place on 18-20 May in London. Both AdvaMed and Eucomed worked closely with our member companies to identify the hottest issues in medical device industry compliance today to shape a truly global, industry specific event. We also worked together to invite accomplished discussion leaders and moderators, and panel participants representing North American and European perspectives and experiences.
The ‘New Approach’ – making standards even better
There are some who are claiming that the EU Commission’s formal objection to eleven standards raised at the end of last year shows that the ‘New Approach’ has shortcomings and that the whole system is ripe for overhaul. I would argue far from it. The New Approach is a very clever system of product regulation, […]
Posted on 08.02.2011
Brussels starts healthy debate on Medical Device Recast
Recent events in Brussels are pointing to a fresh, healthy airing of views and more robust debate on the Recast. (By the way, I’ve noticed that everybody says ‘Recast’ but not too many people know what a ‘Recast’ is. So for all those legal and regulatory ‘techies’ among you, click here, all others steer clear!). […]
Panel-mania? The future of an advisory interpretation
Eucomed published on 23 December 2010 its first Compliance Panel recommendation on the sponsorship of third party educational conferences by Eucomed members. The Panel, an independent body of three external opinion leading experts, was appointed to help provide guidance on the interpretation of the Eucomed Code of Ethical Business Practice as well as drive European harmonisation with […]
Posted on 04.11.2010
Investing in education: Redefining strategy?
Any conference, congress or other important event usually involves some kind of a feedback exercise.