Delays, recalls, and development setbacks caused by undetected impurities in raw materials are more than just costly: they’re a threat to your product’s success. Yet, many medical device manufacturers lack the in-house capabilities, regulatory expertise, or testing knowledge required to verify material quality early enough to make a difference.

The Eurofins Medical Device Services network of laboratories supports manufacturers across the medical device and pharmaceutical sectors with expert raw material testing services designed to minimise risk, safeguard compliance, and optimise manufacturing outcomes. Whether you're qualifying a new supplier, verifying a Certificate of Analysis (CoA) or investigating an inconsistent batch, we deliver the insights you need - fast, accurately, and in full alignment with global regulatory requirements.

Our analytical chemists can validate CoA data or develop methods to characterise material properties beyond nominal purity. Critical impurities often go unnoticed; chemical isomers, water content, and non-volatile species can drastically affect product performance. Our labs are equipped to identify and quantify these threats using:

• Chromatography including HPLC, GC/MS, LC/MS, TOFMS
• Spectroscopy techniques including ICP-MS, NMR, FTIR, Raman
• Microscopy methods such as SEM, TEM, and AFM
• Thermal, mechanical, morphological or rheological analysis tools

For materials like polymers, we assess molecular weight, crosslinking, and crystallinity with a variety of techniques, such as gel permeation chromatography, dilute solution or intrinsic viscometry, and melt flow index.