Medical device sales representatives must report adverse events to comply with FDA guidelines. An adverse event is "any undesirable experience associated with the use of a medical product in a patient." The adverse event should be reported to the FDA when the outcome is: death, life-threatening, hos
Life sciences companies must deal with returned product in a variety of contexts, and must have procedures in place for product preservation, disposal, and/or destruction for each. In creating these procedures, companies are guided by both the FDA’s Quality System Regulations and related guidances
In this webinar, seasoned regulatory attorney Edward C. Wilson, Jr., Partner at Hogan Lovells’ Washington, DC, office, details what an effective complaint-handling system looks like for a medical device company, explains how to measure the effectiveness of such a system, and provides improvements fo
Merely manufacturing, designing and selling a safe product may not satisfy a product manufacturer’s legal duties. Many years ago, courts held that a manufacturer has a duty to warn product users when it learns of risks in its product after sale, even if the product was not defective wh
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 their medical devices.
What is an MDR?
A medical device company must submit a Medical Device Report ("MDR") to the
An unfavorable or unintended outcome may occur as a result of the use of a drug or medical device. When a manufacturer learns of such an outcome, it may be required by law to report it to FDA, depending on the severity of the circumstances. Likewise, Medmarc policyholders may also be required by the