Bringing a medical device to market is no simple process, especially for small or emerging developers. You face intense regulatory pressure, limited resources, and often, limited understanding of what to test, when to test, and which standards apply. From navigating international frameworks to handling unexpected test results, delays at any stage can compromise timelines, budgets, and investor confidence. 

Eurofins Medical Device Services network of laboratories simplifies that journey. Whether you're preparing a 510(k), PMA, or CE marking submission, our global network offers the expertise, capacity, and regulatory insight to support you from early design through commercial launch and post-market. 

For more than 40 years, we've helped device developers meet the stringent demands of safety, efficacy, and usability testing. Our scientists, engineers, and consultants effectively become an extension of your team, offering strategic input as well as precise technical execution. 

We test across all classes and types of medical devices, including: 

• Implants and surgical instruments
• Single-use and combination products
• Active electronic and connected devices 

Across our more than 20 laboratories in North America, Europe, and Asia Pacific, we provide full-scope testing capabilities tailored to your needs, including: 

• Biocompatibility and biological evaluation
• Sterility and microbial testing
• Physical, chemical, and material characterisation
• Extractables and leachables
• Package validation and accelerated ageing
• Shelf life and stability testing 

Eurofins Medical Device Services experts also offer end-to-end support to  develop  comprehensive biological evaluation plans from the design phase, reducing potential retesting and increasing submission readiness. Our laboratories meet or exceed global quality and regulatory standards, with testing performed to: 

• ISO, ASTM, ANSI, and AAMI standards
• ISO 17025, cGMP, and GLP-compliant quality systems
• FDA and global regulatory agency expectations 

Whether you're navigating ISO 10993 or ISO 11607, we understand the nuances of each testing requirement and can guide you through them. If testing doesn’t go as planned, our experts can help interpret results, resolve failures, and optimise retesting strategies to avoid costly delays. 

For small and medium medical device developers, we bring the clarity and structure needed to turn a device concept into a commercial reality. For larger medical device developers, we provide the scale, speed, and customisation required to meet complex programme demands and tight stage-gate timelines. 

From strategy to submission, Eurofins Medical Device Services is your trusted global partner, focused on helping you accelerate innovation, with scientific insight, testing excellence, and regulatory guidance you need to bring safer medical devices to patients worldwide.