Publications
Risk Management (5)
Risk Management 360: The Relationship Between Complaint Handling and Products Liability
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...
MTLI: Education of the Industry, by the Industry and for the Industry
The Medical Technology Learning Institute (MTLI) is the education department of AdvaMed, an association whose member companies produce nearly 90 percent of the medical devices, diagnostic...
Drafting Informed Consent Forms | Medmarc
The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed...
Preemption Defense for Generic Pharmaceutical Companies
Generic pharmaceutical manufacturers recently received an historic victory from the highest court in the land. In Pliva, Inc. v. Mensing, the United States Supreme Court held that federal...
Selecting Employee Witnesses
Question:We are a small manufacturer of medical devices and have just been served with our first lawsuit. We have been asked by appointed counsel to select someone within our company...
Case Study: Which Way Do I Turn? Understanding the difference between professional liability & products-completed operations
There are more than 7,000 manufacturers of medical devices in the US, mostly small- and medium-sized enterprises, with more than 80% having fewer than 50 employees1. Many small life...
International Clinical Trials: Look Before You Leap
Logistical problems and financial pressures prompt many medical technology and life sciences companies to sponsor human clinical trials outside the borders of the United States. As...
Vaccine Injury Compensation Program
The early to mid-1980s was an era of considerable vaccine-related litigation. In response to increasing litigation costs and damage awards, many vaccine manufacturers left the market....
Medical Device Reports (MDRs)
The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of...
What are the best practices for dealing with FDA inspections?
Question: What are the best practices for dealing with FDA inspections? Answer: Many life sciences companies may regard the prospect of an FDA inspection with dread, in part because...