Medical Devices
Medical devices rely on tightly controlled materials and manufacturing processes to ensure safety, performance, and reliability. Device materials and assemblies are widely used across implantable and non-implantable devices, disposable components, drug-delivery systems (project-dependent), diagnostics, and sterile packaging. Small changes in material composition, additives, residues, surface chemistry, and particulate contamination can create major risks such as biocompatibility concerns, leakage, discoloration, adhesion failure, brittleness, or particulate shedding.
We provide analytical testing and materials characterization for device materials, components, and failure-related residues, supporting R&D, supplier qualification, incoming QC, process change verification, and root-cause investigations. Our multi-technique approach delivers clear, decision-ready results—especially for “what changed?” comparisons and contamination source identification.
Why Testing Matters for Medical Devices
Medical device quality depends on controlling:
Material identity and formulation consistency (supplier equivalency, lot changes)
Surface condition and cleanliness (adhesion, bonding, sterilization compatibility—project-dependent)
Organic residues and extractable-like contaminants (project-dependent)
Ionic and metallic contamination linked to corrosion, discoloration, or reliability drift
Particulate contamination and shedding affecting cleanliness requirements
Aging and stability behavior (discoloration, brittleness, cracking, fogging—project-dependent)
Failure analysis (leaks, delamination, bonding failure, stress cracking)
Our lab uses orthogonal methods to identify what changed, where it came from, and how to verify corrective actions.
FAQs
Can you identify unknown polymers or silicones?
Often yes. FTIR/Raman is typically the first step; Py-GC/MS, GC-MS, or NMR may be added for complex blends or additives.
Can you help with particulate investigations?
Yes. SEM-EDS + spectroscopy is a common workflow to identify particles and differentiate likely sources.
Can you evaluate cleaning residue or surface treatment effectiveness?
Yes (project-dependent). Surface techniques such as XPS/TOF-SIMS can be used to compare before/after conditions.
Do you need a reference/control sample?
Strongly recommended. Side-by-side comparisons provide faster and more defensible conclusions.
Is the analysis destructive?
Most analyses are minimally destructive, but some options (e.g., depth profiling or certain prep steps) can be destructive in the analyzed area. We will clarify in the method plan.