Extraterritorial reach of the FCPA: recommendations for U.S. medical device companies with activities in Europe.

Traditionally medical devices companies manage business compliance with anti-corruption and anti-fraud rules in a document-oriented way that does not always yield optimal results for the company. As a result, compliance issues are not optimally managed by the companies. Now that medical devices companies become ever more internationally active, they must also take into account the international dimensions of business compliance. This article intends to provide U.S. medical devices companies with activities in Europe with an insight in business compliance risks in the European Union (EU) and the risks related to U.S. statutes that may be applicable to a U.S. company's activities overseas. The article proposes a process-oriented and IT-supported way of structuring an international business compliance program, resulting in increased effectiveness of the program and increased competitiveness and risk management of the company as well as a high degree of acceptance of the procedures by the company's employees.