About Regulatory and ethical compliance for medical devices

Due to the diversity of the medical device market, the regulatory framework for medical device manufacturing and recast across Europe has been criticised as being too fragmented and lacking clarity. For European companies the challenge now remains to adapt to harmonisation and keep their processes flexible for possible further changes. As the majority of manufacturers also operate within the US market, achieving compliance with FDA regulations also needs to be considered.

In addition to these challenges, compliance with anti-corruption laws is becoming a growing area of concern as growing scrutiny by regulatory authorities and the media has made failure in this area unacceptable. Ethics involved in the relationship between manufacturers and healthcare professionals or third parties remains a grey area.

VIBpharma’s Regulatory and ethical compliance for medical devices conference being held on the 2nd and 3rd December 2008 in Barcelona will bring a unique perspective to the major challenges facing manufacturers today; the first European conference of its kind to address the growing role of ethics in achieving compliance. Through a series of presentations and roundtable discussions led by regulatory authorities, manufacturers and Notified Bodies, this event will provide strategic approaches and best practice solutions to current and future compliance challenges