Every material matters. Every detail counts. Whether it’s a shift in raw material supplier, a new product design, or concerns around degradation or contamination, identifying the chemical and physical makeup of your medical device materials is critical. The challenge for many manufacturers lies in knowing what to test, when to test, and how to respond when results reveal an “unknown”. That uncertainty can lead to costly delays, regulatory pushback, or even compromised patient safety.

The Eurofins Medical Device Services network of laboratories will provide you with clarity and confidence. Our global team of PhDs and highly trained chemists operate more than 500 state-of-the-art chromatographic systems and over 12,200m3/430,000ft3 of stability chambers, delivering unmatched analytical power across the full spectrum of material characterisation.

We help medical device manufacturers confirm the identity, purity, safety, and consistency of materials at any stage from R&D through to commercialisation. Our chemical and physical testing capabilities include:

• Confirmation of raw material purity
• Degradation and dissolution studies on resorbable polymer devices or bone ingrowth coatings
• Safety profile assessments of additives in plastic components
• Evaluation of supplier changes, processing modifications, or sterilisation method impacts
• Detection of contaminants such as machining oils and cutting fluids
• Early-stage formulation testing and product development support

Our ISO 17025-accredited laboratories are fully equipped to conduct studies to the latest regulatory standards and pharmacopeial methods, including USP <467>, <621>, <905>, <197>, <232>, <233>, <788>, <791>, <341>, and <1207>. We also support ISO 10993 and ISO 18562 guidance for chemical characterisation in biological evaluations.

• Antimicrobial Agents (USP <341>)
• Appearance Evaluation (Visual)
• Chromatography (USP <621>)
• Container Closure Integrity Testing (USP <1207>)
• Dosage Uniformity (USP <905>)
• Elemental Impurities (USP <232>, USP <233>)
• Material Identification (IR) (USP <197>)
• Melting Range (USP <741>)
• Particulate Matter in Injectables (USP <788>)
• pH (USP<791>)
• Residual Solvents (USP <467>
• Specific Optical Rotation (USP <781>)
• Water Content (USP <921>)

Whether you need particulate matter testing, water content analysis, residual solvents detection, or elemental impurities assessment, we have the instrumentation and insight to deliver clear, defensible results. And if your team encounters an “unknown” compound, we can identify it using validated techniques and extensive in-house spectral databases, helping to “rescue” negative results and avoid time-consuming rework.

If you’re unsure when to engage or how your current materials strategy may affect timelines or compliance, our team can advise on study design and testing scope. Our integrated approach ensures alignment with global regulations while minimising delays and resource impact.

From individual components to finished devices, our chemical and physical analysis services provide the insight needed to make confident decisions, protecting both your product and your patients.