Publications
CMO Liability: Protect Your Business From Additional Risk
CMO Liability: Protect Your Business From Additional Risk Part three of a three-part series on the Contract Development and Manufacturing industry and potential products liability and...
Claims Case Study: Negligent Design Defect
Case Study: Negligence Claim Based on Design Defect Seasoned Experts, Swift Action Led to a Defense Verdict for Medmarc Insured EXECUTIVE SUMMARY The owner of a motorized scooter carrier...
Litigation for Life Science Companies: Aspects of Litigation That Should Affect How You Run Your Business
The prior twelve articles in this series have focused on products liability in general and the various aspects of designing, making, and selling medical devices. These articles pointed...
Post-Sale Duties: FDA Law and Regulations
Introduction As described in the previous article, manufacturers of medical devices sold in the United States have two bodies of laws to consider after sale: the common law of product...
Marketing Defects and Warranties
Manufacturers of medical devices and providers of services concerning these devices can be held liable for injury, damage or economic loss suffered by a purchaser and a third party such...
Introduction to Products Liability 360
Products liability has created problems for product manufacturers, sellers and product-users for centuries. More recently, however, there has been an expansion of liability well beyond...
Supplier Controls
Medical device manufactures often use component parts provided by a supplier to complete a finished medical device. Manufacturers should be concerned with the reliability of supplier...
Quality System
The term "quality" refers to a medical device's fitness for its intended use. To ensure quality, the Food and Drug Administration (FDA) requires the manufacturers of medical devices to...
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...