The medical device packaging design, testing, and validation process can be intricate and time-consuming, facing intense regulatory scrutiny and often being the largest cause of FDA recalls. Starting medical device packaging validation too late in the design process can create significant challenges for most new product launches.
Life Science Outsourcing is a medical device contract manufacturer, packager, and sterilization provider for Class II and Class III sterile medical devices, catering to both small and large OEMs.
Medical Device Packaging Capabilities: We assume responsibility for the following medical device contract assembly & packaging processes, allowing you to focus on other aspects of your business:
Today’s FDA and ISO regulations mandate numerous protocols and test reports to validate that a sterile medical device package effectively safeguards its contents and maintains sterility throughout manufacturing, storage, distribution, and aseptic transfer to the end-user. These complex package validation regulations can lead to compliance challenges, recalls, and in the worst cases, patient harm.
Life Science Outsourcing’s medical device contract manufacturing and packaging services include:
Our smart sterile package design approach begins with understanding which package formats ensure the required levels of cleanliness and sterility. We strike a balance between protection, ease of use, and material costs.
We provide photorealistic renderings that are indistinguishable from the real product, offering a faster alternative to physical prototypes.
Life Science Outsourcing employs rapid prototyping processes and quick-change thermoforming equipment.
Our sterile field experts ensure that package contents can be aseptically transferred into the sterile field, in compliance with ISO 11607 and FDA regulations.
We minimize material and transportation costs while ensuring your entire packaging system, including cartons, maintains sterility during distribution and storage in accordance with ISO 11607 regulations.
DHR-Ready Sterile Packaging Validation Protocols and Reports: We supply all the unique protocols and reports for your packaging validation, tailored for your technical and regulatory files.
To save time, money, and potential headaches, we collaborate closely with accredited package testing labs for final sterile packaging validation testing. We conduct internal feasibility tests before performing a simulated distribution study, guaranteeing the package passes the test on the first attempt.
We design and execute studies that adhere to ISO guidelines for stability and shelf life in the shortest possible timeframe.