Packaging provides so much more than merely branding to a product. It is both a vital protective layer and a critical component of quality and regulatory compliance. When you’re bringing a medical device to market, the packaging you wrap it in must be able to withstand transport, storage, and ageing, while maintaining sterility, integrity, and clear labelling.

With so much to think about, the risk of timelines slipping due to a failed packaging design is always present – especially when you lack the internal resources and experience needed to conduct the full scope of packaging testing in-house.

The Eurofins Medical Device Services network of laboratories maintains quality systems compliant with cGMP, GLP and ISO 17025, and conducts testing in accordance with ISO, ASTM, ANSI, AAMI standards, to evaluate every detail of your primary, secondary and tertiary packaging systems. Our services cover seal strength, barrier integrity, ageing studies, and distribution simulation – all under ISO 11607, ISTA, ASTM, and other recognised international regulatory standards.

With rising supply chain complexity and regulatory scrutiny, our package testing engineers partner with you to:

• Avoid costly redesigns by validating packaging performance upfront
• Conduct accelerated and real-time ageing studies to confirm shelf life
• Demonstrate barrier integrity through dye immersion, HVLD, and microbial ingress testing
• Meet FDA 21CFR211.94 and ISO 11607 Part 1 and Part 2 requirements
• Validate usability and UDI labelling for clinical environments

We simulate real-world transport conditions to test your product’s resilience under stress, using methods such as:

• Drop and impact testing
• Environmental chamber conditioning
• Label durability including Sutherland rub tests
• Seal strength and burst testing
• Vibration simulation

Whether you’re preparing for global transport or managing validation for regulatory submission, our expert packaging engineers help you navigate test selection, design protocols, and interpret results. If your packaging requires a sterile barrier, we  link our testing to sterile packaging [GS1] design and human factors studies to ensure full system validation from manufacturing to point of use.

From blister packs and pouches to bottles and trays, we tailor testing to your configuration, material type, and risk classification. If you lack internal testing resources or are launching a novel delivery system, our packaging engineers partner with you from design verification through to post-market support.

With decades of experience and a global network of laboratories, Eurofins Medical Device Services delivers fast, flexible, and compliant solutions to support your packaging strategy, ensuring your devices stay protected, and your project stays on track.