Medical device manufacturers face unrelenting pressure to meet regulatory requirements, ensure patient safety, and deliver products to market on time. But choosing the right time to involve a laboratory for validation, managing cost and quantity of multiple samples required, and ensuring the reliability of your results, all while keeping timelines, can be daunting. Failing to control bioburden introduces unacceptable risks to device sterility, jeopardises regulatory approvals, and can lead to costly delays.

Leading manufacturers turn to the Eurofins Medical Device Services network of laboratories. Why? Because we provide validated bioburden testing that establishes and maintains effective sterilisation processes –  according to requirements of ISO 11737-1, ISO 11737-2, and ISO 11137-3 – and protects end users from microbial contamination.

We offer full-service microbiological support for a wide range of medical devices and their components. Whether you are in early-stage development, preparing for a 510(k) submission, or managing quarterly dose audits, our scientists will work with you to design testing programmes tailored to your product type, regulatory needs, and manufacturing process. Our bioburden testing capabilities include:

• Enumeration of total aerobic bacteria, fungi, anaerobes, and spores
• Method validation using VDmax or other methods compatible with your device
• Recovery efficiency studies (repetitive or simulated recovery)
• Screening for adverse materials affecting microbial recovery
• Suitability testing and recovery factor determination
• Use of the Most Probable Number (MPN) method for low-bioburden products

All testing is performed in accordance with ANSI/AAMI/ISO 11737-2, USP <61>, and other global standards. Our extraction and microbial enumeration methods (plate count, membrane filtration, or direct immersion in nutritive media) are carefully selected based on product composition, material properties, and intended sterilisation method.

Validated testing is a critical part of any sterilisation programme, whether you are using ethylene oxide, radiation, or another method. By identifying worst-case products and establishing robust bioburden baselines, we help you mitigate risk, optimise dose setting, and ensure ongoing compliance with:

• Comprehensive data analysis and reporting, including microorganism identification
• Guidance on selecting representative and randomised production samples
• Support for quarterly and monthly testing schedules

Eurofins Medical Device Services brings extensive regulatory knowledge, advanced instrumentation, and a collaborative approach to every project. With strategically located laboratories and global support, we deliver efficient turnaround times and unmatched technical depth.

Let us help you eliminate uncertainty, validate your processes, and deliver medical devices that meet the highest microbiological safety standards every time.