Preventing Damage and Maintaining a Sterile Barrier: Why Medical Device Distribution Testing is Necessary
Medical devices must be reliably shipped across the country and around the world to arrive intact at their destinations for a positive impact on human health. Yet improper packaging preparation can mean the sometimes life-saving medical devices arrive in less-than-optimal condition. Medical device manufacturers must take all mandated and recommended packaging steps to ensure such a dismal outcome does not come to pass. That includes medical package testing.
When does medical package testing require a protocol? What exactly is involved? Read the answers here, along with why a proper written and approved protocol should always be considered.
What is Dunnage and How Can it Reduce Medical Package Testing Costs?
What is dunnage and what does it have to do with medical package testing? Find out in our latest article which details the ways dunnage can reduce medical package testing costs without derailing regulatory approvals.
Successfully designing, implementing, and validating effective packaging that protects medical devices and maintains sterility when needed is a complex challenge.
3 Keys to More Efficient Distribution Simulation Testing
Distribution simulating testing, also known as ship testing or distribution testing, is an essential step in the process of safely bringing a medical device to market.
ISO 11607 – Answering Manufacturers’ Most Common Questions
Life Science Outsourcing has an in-depth understanding of ISO 11607 and all the regulatory requirements that come with successfully developing and validating medical package testing as part of the broader manufacturing process. Here are five questions we often hear from clients and partners.
When it comes to aging, many 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.