ISO 11607 is the defining standard for medical package testing and validation. As the consensus standard for the Food & Drug Administration (FDA), no device can expect to find its way to market without an in-depth understanding of the standard and how to meet the requirements it spells out.
Lots of medical device manufacturers focus on accelerated aging and successfully establishing an estimated shelf life for medical devices. But another aging test often gets overlooked – real-time aging. Learn the right time to start real-time aging and some best practices for results that comply with ISO 11607.
Does your medical package testing project need a sterile barrier accelerated aging? Find out in our what, why, and how explanation of this process.
Medical device, pharmaceutical, and biotech companies must follow stringent medical device packaging validation processes to obtain what they need for an FDA or EU submission: The coveted validation report. Your terminally sterilized medical devices cannot [...]
How many medical package testing samples do you need? Read common processes testing providers use to make the determination!
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.