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Medical Devices
Chemical Characterization and Extractables & Leachables (E&L) Testing That Helps You Safely Bring Medical Devices to Market
Medical devices demand safety, performance, and regulatory compliance throughout their lifecycle. Quantum Analytics Group provides specialized analytical chemistry and physical testing for medical-device materials, components, and finished devices, helping manufacturers identify chemical constituents, characterize materials, evaluate extractables and leachables (E&L), investigate impurities and degradation products, and generate reliable data to support product development, quality assurance, and regulatory submissions. With more than 30 years of experience supporting devices including stents, implants, sutures, surgical staples, and syringe systems, Quantum delivers scientifically defensible test results that help ensure device safety, purity, performance, and regulatory confidence.
FOCUSED ANALYTICAL SUPPORT
Choose The Study Path That Matches Your Device Question
Rather than forcing every project into a standard package, Quantum Analytics Group aligns sample preparation, analytical techniques, reporting, and quality requirements with your material, device configuration, intended use, and development stage.
ISO 10993 Chemistry
Chemical Characterization
Analytical characterization of device materials and chemical constituents within a risk-management framework, including targeted and non-targeted approaches as appropriate.
Organic & Inorganic
Extractables and leachables
Study design, controlled extraction, screening, identification, and quantitative or semi-quantitative evaluation of compounds that may migrate from a device or component.
Syringes
Silicone quantity testing
Testing aligned with ISO 7886-1 Annex F for evaluating the quantity of silicone associated with sterile hypodermic syringes for single use.
Materials
Polymer, rubber, metal & alloy analysis
Composition and impurity testing for device materials, including selected testing aligned with ISO 6101, ISO 22961, and ISO 7627 when applicable to the material and scope.
Lifecycle Changes
Comparability and change assessment
Analytical comparison of materials, suppliers, processes, sterilization conditions, aging states, or manufacturing changes to identify meaningful chemical differences.
Problem Solving
Unknowns, residues & degradation products
Investigation of unexpected impurities, contaminants, sterilization residues, corrosion products, polymer degradation, and other chemical causes of device-quality concerns.
Techniques Selected For The Question—Not Just The Instrument List
Successful analytical studies begin long before the first sample enters the laboratory. They begin with understanding the device, its materials, manufacturing process, clinical application, and the regulatory questions the data must answer. Our scientists design each study around these factors—selecting appropriate extraction conditions, analytical platforms, reporting thresholds, and validation strategies—to produce scientifically defensible results that withstand technical and regulatory scrutiny. Whether supporting ISO 10993 chemical characterization, extractables and leachables (E&L) studies, impurity investigations, material characterization, or combination products, our objective is not simply to generate data, but to generate the right data for informed scientific and regulatory decision-making.
GC / GC-MS
Volatile and semi-volatile organic compounds
LC/LC-MS
Non-volatile and thermally labile compounds
ICP-MS/ICP-OES/AAS
Elemental composition and inorganic impurities
FTIR Spectroscopy
Material identification and comparative analysis
Targeted Chromatography
Known compounds, residues, and release profiles.
CASE STUDY
Supporting a First-of-Its-Kind Medical Device–Drug Combination Product in Europe
Only a few years after its founding, Quantum Analytics Group was called upon to assist a global medical device manufacturer facing one of the industry's earliest medical device–drug combination product regulatory challenges in Europe.
The product—an innovative antibacterial-coated surgical suture—combined a medical device with a pharmaceutical active ingredient. Because the antimicrobial coating was regulated as a drug, the product required an unprecedented level of analytical characterization and a comprehensive pharmaceutical-style regulatory review.
How Quantum Support the Client
Quantum worked alongside the manufacturer's scientific and regulatory teams to develop the analytical strategy needed to address the regulatory authority's concerns. At the time, the reviewing authority requested additional impurity characterization data that had not previously been generated, creating a significant technical and regulatory challenge that threatened to delay product approval.
Leveraging its expertise in impurity characterization, method development, and mass spectrometry, Quantum Analytics Group developed and executed a focused analytical program that generated the scientifically defensible data needed to support the submission and advance the product toward approval.
That project marked the beginning of a long-standing scientific partnership. More than 20 years later, Quantum Analytics Group continues to support this client with analytical services, reflecting the confidence leading medical device manufacturers place in our scientific expertise, responsiveness, and commitment to delivering reliable, regulatory-quality data.
Today, Quantum applies that same problem-solving approach to support manufacturers worldwide through chemical characterization, extractables and leachables (E&L) studies, impurity investigations, material characterization, method development, and analytical support for complex medical devices and combination products.
START A CONVERSATION
Bring Clarity to Your Product Challenges
Have a product, method, analytical or testing issue? Schedule a FREE consultation with our team by submitting the form on this page. We’ll discuss your challenges, walk you through potential testing strategies, and help you move forward with confidence.
Monmouth Junction, NJ 08852
Corp & Admin Offices:
30 N Gould Street Suite 10683
Sheridan, WY 82801 USA