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As ABHI celebrates its 30th anniversary today, Peter Ellingworth, Chief Executive of the association discusses the past, present and future.  1.  In the 30-year history of ABHI, what have been the biggest changes? Our industry has changed significantly over the last 30 years, from being simply product based, to delivering value-based service solutions and increasingly […]

As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships […]

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.

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, […]