Medical device contract manufacturing is the outsourced fabrication of a medical device for the medical marketplace. The Food and Drug Administration (FDA) has very specific criteria to define a medical device.
Medical devices must be sterilized and prepared before use. There are several best practice and integrity recommendations to consider when your devices require sterilization, including cleaning and packaging.
Design Terminally Sterile Packaging: 3 Ways to Prevent ISO 11607 Package Design Failure (Infographic)
Your medical device product likely needs terminally sterile package design to deliver to market. At this point, you’ve progressed through product development and likely developed a sterilization process. You’ve now arrived at performance testing the sterile barrier system. But you may have concerns about the best way to evaluate your packaging system.
In February, LSO participated, for the 17th consecutive year in the MD&M West show at the Anaheim Convention center. This year, Barry Kazemi, LSO’s CEO & President, had been invited to be one of the [...]
According to the CDC, in American hospitals alone, hospital-acquired infections (H.A.I.) account for an estimated 1.7 million infections and 99,000 associated deaths each year (source). A recent study in Emerging Infectious Diseases found that hospital-acquired [...]
Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in [...]
As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects. When a project reaches me, often times the packaging has already been created and [...]
Theoretically, even though the tax will have a major negative initial impact on Medical Device companies, it will end up generating more business, due to the increased patient population having access to healthcare, and having procedures which require the use of medical devices. However, that is not likely to happen.
5 Project Management Rules for the Success of your Medical Device LaunchFulfillment & Distribution Services, LSO Blog, LSO Incubator Services, Medical Device Manufacturing, Medical Package Testing, Offshore Manufacturing, Sterilization Validation Services
At LSO, we typically manage 50-55 new product launches a year. This doesn’t include helping existing customers with product revisions and follow on work. This is a launch rate that far surpasses that of many [...]
We are happy to announce that LSO is in the final phases of installation of two 8 cubic foot EtO sterilizers. We expect them to be certified and ready for production by the end of [...]