Medical Device Package Testing
Life Science Outsourcing, an FDA-registered and ISO 13485-certified Contract Manufacturing Organization, provides packaging design, validation, and testing through our ISTA Certified Lab, ensuring cost efficiency and regulatory compliance.
Services and Expertise
Our medical package testing experts in our ISTA-certified packaging test lab (ID Number ST-2339) are committed to ensuring a complete and comprehensive packaging solution that meets regulatory requirements and can withstand the rigors of shipping and distribution. Our testing and validation services are based on ISO 11607-1:2019 and adhere to FDA, ISO, EN, and CE Mark requirements. Each partnership includes an in-depth evaluation of the product and package with tailored protocols and rationale, detailed test results, and a comprehensive final report with regulatory considerations and next steps.
Package Validation Testing
From visual inspection and peel strength tests to dye penetration, bubble emission, and burst tests, our package validation testing services ensure compliance with ISO 11607 and applicable ASTM standards.
Distribution Simulation Testing
From drop, vibration, and compression testing to atmospheric conditioning, our distribution simulation testing exposes products and packaging to real-life hazards, ensuring compliance.
Accelerated Aging & Realtime Aging
From real-time aging to accelerated aging, our stability testing services including our accelerated aging calculator help manufacturers determine shelf life and the effects of aging on materials.
Your Partner in Innovation
Life Science Outsourcing’s Medical Package Testing services offer a turnkey solution for medical and pharmaceutical start-ups as well as original equipment manufacturers. With more than two decades of experience, our manufacturing and engineering experts work as an extension of your team, turning ground-breaking concepts into commercial-ready products.
We are ISO 13485 certified and FDA-registered with 10,000 square feet of state-of-the-art Class 10,000/ISO 7-rated cleanroom space.
Standards
Life Science Outsourcing has in-depth experience in compliance with a wide range of standards related to medical package testing. Both the FDA and international regulatory bodies emphasize compliance with ISO 11607; Packaging for terminally sterilized medical devices. This standard defines the test requirements necessary to ensure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport, or storage.
Our experts and processes provide package testing services that comply with the following standards:
- ANSI – American National Standards Institute
- AAMI – Association for the Advancement of Medical Instrumentation
- ASTM – American Society for Testing & Materials
- ISO – International Organization for Standardization
- ISTA – International Safe Transit Association
Don't take our word for it!
Frequently Asked Questions
We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently. Get answers to the most common questions for Medical Package Testing and all our services.
One-Stop Shop
From startups to multinational corporations, we’ve helped pharmaceutical companies and medical device makers of all sizes turn powerful ideas into profitable offerings. Our unique model serves as a turnkey solution offering unparalleled time to market through a full spectrum of regulated services and specialized high-value capabilities.
