Publications
Risk Management (3)
Proactive Document Management for Device Manufacturers – Part 2
Part 1 of this article discussed the importance of documents in designing and manufacturing products and how the existence of or lack of drawings, plans, and other records has hurt...
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 Learned Intermediary Doctrine
The Doctrine The Learned Intermediary Doctrine provides that a drug or medical device manufacturer has no legal duty to warn consumers of a drug or medical device’s harmful side effects...
Effective Supply Chain Management for Medical Device Shipments
Medical device manufacturers face a daunting challenge in today's market. In addition to understanding stringent government regulatory requirements and FDA-mandated current Good...
Document Management: How Life Sciences Technology Companies Can Protect Themselves
Product Liability is a Significant Risk to Life Sciences Technology Companies While some product liability lawsuits grab media attention, 90% are settled out of court through agreements...
Spoliation of Evidence
Upon becoming aware of a potential or actual lawsuit, the relevant parties have a responsibility to preserve any evidence potentially related to it. A party who purposely or negligently...
Clinical Trial Insurance: Comparing the Coverage Alternatives
Most buyers of clinical trial insurance look for broad coverage at an affordable, predictable cost. The difference in coverage offered by insurance companies can be confusing and the...
Risk Management 360: Product Classification: Products Liability Implications
In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing...
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...