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...
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...
Complaint Handling for Medical Device Manufacturers
Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include:...
Case Study: Animal Dewormer
ANIMAL HEALTH PRODUCTS EXECUTIVE SUMMARY: This case involves an equine dewormer used by a horse breeding operation. Fifty-four horses deceased shortly after use of the product, and their owner...
Defending a Products Liability Lawsuit
Medical device and drug manufacturers have no intent or desire to introduce harmful devices or drugs into the marketplace. In addition, FDA’s strict regulation of these companies is...
Developing a Medical Device Recall Action Plan
Medical device recalls are initiated when a medical device is defective, poses a risk to health, or both. The medical device manufacturer is generally charged with voluntarily initiating...