Each issue includes summaries in German, French and Spanish

In the current issue...

ODE: Donna-Bea Tillman discusses the current trends and future direction of the US Office of Device Evaluation
Custom-made devices: Haroon Atchia examines the requirements in Directive 93/42/EEC for custom-made devices and systems and procedure packs
Dispute resolution: Elisa Harvey explains the procedures for resolving disputes with a US FDA review team
Latin America: Victoria Clark provides an overview of the medical device regulatory requirements in Latin America
Regulatory updates: Argentina, Australia, Brazil, Canada, China, Colombia, Denmark, Europe, Finland, France, Germany, India, International, Ireland, Japan, Mexico, Portugal, Switzerland, Thailand, the UK, the Ukraine and the USA plus the environment, standards and regulatory personnel on the move
Country overview: the medical device regulatory requirements in Israel
Elemental Essentials: finite element analysis (FEA) in medical product development
GHTF: German translation of GHTF/SG2/N54R8:2006 (part 1)
Reporting: Medical device reporting requirements in Australia, Canada, the EU and the USA