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!
“We are excited about the partnership and the growth opportunities it presents,” said Barry Kazemi, Founder and CEO of LSO. “PPC’s experience in the medical device and life sciences industries will enable us to build upon our existing capabilities and offer more complete product life cycle support to our valued customers.”
Medical device sterilization validation and documentation processes can seem overwhelming. It doesn’t have to be! Find your answers here.
It is ideal to understand industry best practices when preparing to sterilize your medical devices through an outside resource. There are seven industry best practices in this process which you can use to set expectations [...]
Pus. Blood. Dirt. Foreign particles. All these and more may be left behind on a medical device after medical procedures are complete. Definitely not what a healthcare professional wants to reuse, and most certainly not what a patient wants used on them!
Is gamma sterilization the best choice for your medical device? Learn more about this sterilization process and what it’s used for.
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.
Learn the difference between real time aging and accelerated aging for your medical device package testing project.
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.