Bridging Compliance, Material Integrity, and Risk Reduction
In today’s medical device industry, innovation must be matched by accountability. While product design fuels performance, safety and compliance hinge on the unseen, the chemistry behind your materials. From the earliest stages of R&D to final product validation, analytical chemistry testing plays a critical role in ensuring that every component in contact with the human body is stable, clean, and compliant.
At Microchem Laboratory, we help manufacturers bring complex medical devices to market with confidence. Our chemistry testing services go beyond routine measurements, they deliver regulatory-grade data that supports sterilization validation, bioburden control, and long-term product integrity.
Why Analytical Chemistry Testing Is the Backbone of Medical Device Safety
Every material used in a medical device from polymers and adhesives to coatings and metals carries potential chemical risks. If not thoroughly evaluated, devices may leach harmful compounds, contain residual solvents, or fail under stress. That’s why analytical chemistry testing is more than a safety measure, it’s a regulatory imperative under standards like ISO 10993, FDA 21 CFR, and ICH Q3D.
At Microchem Laboratory, our analytical services are designed for real-world device challenges. We help clients:
· Detect impurities, degradation products, or contamination
· Validate material consistency across batches and suppliers
· Screen for toxic elements, residual solvents, or heavy metals
· Perform extractables and leachables studies when required
This proactive analysis prevents product recalls, supports cleanroom compliance, and helps meet stringent approval timelines in the U.S., EU, and beyond.
Our Tools of Precision: HPLC, ICP-MS, FTIR, and Beyond
Reliable data requires precision instrumentation. That’s why Microchem’s analytical lab is equipped with industry-leading technologies, including:
· HPLC (High-Performance Liquid Chromatography) – Ideal for quantifying active ingredients, preservatives, and trace impurities.
· FTIR (Fourier-Transform Infrared Spectroscopy) – Confirms material identity and detects chemical shifts due to processing or aging.
· ICP-MS (Inductively Coupled Plasma Mass Spectrometry) – Detects trace elements and heavy metals down to parts-per-billion levels.
· GC-MS and UV-Vis – For volatile compound screening, residual solvent analysis, and concentration verification.
Each method is validated under GLP and ISO 17025 standards, ensuring results are not only accurate but also admissible in regulatory filings.
Choosing the Right Chemistry Testing Lab: What to Look For
Not all labs are equipped to handle the complexity of medical device testing. Inconsistent methods, generic reports, or lack of regulatory fluency can delay your launch and invite unnecessary risk.
Microchem Laboratory is built to serve the medical device industry with:
· Deep regulatory alignment – Our methods are tailored to FDA, ISO, and ICH expectations
· Industry-specific experience – From wound care and diagnostic kits to implantables and reusable tools
· Speed and scalability – We work with startups, contract manufacturers, and global brands to deliver timely results at any volume
We don’t just test, we help guide your product through the science of compliance.
Chemistry Testing as Part of a Holistic Compliance Strategy
Analytical chemistry is only one part of a successful testing program but it's the one that can make or break your product’s ability to pass regulatory review. Whether you’re verifying material specs, troubleshooting a failed lot, or preparing for post-market surveillance, chemistry testing informs your broader strategy for risk management, regulatory compliance, and device quality.
At Microchem Laboratory, our services integrate seamlessly with other key areas of device validation, including:
· Sterilization Validation – Confirming both efficacy and chemical safety
· Bioburden Testing – Supporting microbial control before sterilization
· Cleaning Validation – Ensuring chemical residues are effectively removed
This comprehensive approach not only helps manufacturers meet evolving global standards, it also builds lasting trust with healthcare providers and end users.
Supporting Innovation with Chemistry-Driven Clarity
In a market where scrutiny is high and tolerance for error is low, every molecule counts. Whether you’re launching a breakthrough product or refining an existing line, analytical chemistry testing gives you the clarity to move forward and the confidence to pass inspection.
Microchem Laboratory combines scientific rigor, regulatory understanding, and deep industry insight to deliver results that matter. Our mission is simple: to help you create safer, more effective medical devices through chemistry, compliance, and collaboration.
