How Many Medical Device Package Samples Are Required for Package Testing?
How many medical package testing samples do you need? Read common processes testing providers use to make the determination!
Medical Device Package Distribution Testing: Shake, Rattle, and Roll
Medical device distribution testing is an important part of delivering your product to market. Learn more about the “shake, rattle, and roll” medical package testing method.
What is the Difference Between Real Time Aging and Accelerated Aging in Medical Package Testing?
Learn the difference between real time aging and accelerated aging for your medical device package testing project.
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.
Dye Penetration Testing – Recent ASTM Enhancements
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 [...]
3 Key tools to mitigate ISO 11607 Package Design failure
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 [...]
Medical Device Tax – Something’s Got to Give
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 Launch
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 [...]
Boxed to Perfect Standards
The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device. The primary standard governing medical device packaging and shelf life validation is ISO 11607-1
Distribution Simulation Testing, ASTM D4169 & ISTA
Distribution Simulation Testing assesses a medical package’s ability to protect and maintain sterility of the products within. This is accomplished by exposing the package to real-life hazardous conditions that it could face through the handling, [...]