Publications
Global Solutions
European Union “CE” Mark
Medical device manufacturers seeking to export products to European Union (EU) countries must consider whether they need to obtain the CE mark for their products. CE is an acronym for...
The Foreign Corrupt Practices Act
What is the Foreign Corrupt Practices Act? The Foreign Corrupt Practices Act (FCPA) is a federal law that makes it illegal for companies to make payments to foreign government officials...
Mitigating the Risks of Foreign Suppliers
Question:How can life sciences companies mitigate the products liability risks associated with using foreign suppliers? Answer:As pricing pressures weigh on medical device and...
The Basics of Contractual Risk Transfer
In an age of outsourcing, before a finished medical device or pharmaceutical product reaches its end user, it will be "touched," literally and figuratively, by multiple vendors, such as...
Risk Shifting Through Contracts: Meaning & Examples
Abstract: In an increasingly global economy, medical device manufacturers are finding that they must rely more and more on supply chains in order to control costs and successfully compete...
Controlling Your Supply Chain
Question:What lessons can manufacturers learn from the heparin contamination crisis? Answer: Heparin, an injectable drug still in wide use as an anticoagulant (blood thinner),...