Medical Devices

Testing That Helps You Safely Bring Medical Devices to Market

Medical devices demand safety, performance, and regulatory compliance at every step. With new technologies, strict standards, and high risks, you need testing you can trust.

Quantum provides analytical chemistry and physical testing for both qualitative and quantitative assessment of medical devices. Services include material characterization, leachables/extractables testing, and degradation product analysis. With over twenty years of experience working on devices like stents, implants, sutures, surgical staples, and syringe bodies, you gain test data that supports safety, purity, and reliable performance.

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How Medical Device Testing Works

We begin by selecting the relevant components and materials—polymers, metals, alloys, or sterilization residues—and identifying potential risk points like leaching, degradation, or impurities. Then we apply both chemical and physical testing (extractables/leachables, drug release or elution profiles, impurity profiling, etc.) to produce data that meets regulatory, R&D, and quality needs.

Application

Practical Uses of Medical Devices:


  • Assess material characterization and impurity profiles for device components
  • Evaluate extractables, leachables, and residuals from sterilization processes
  • Study degradation products from polymeric, metal, or alloy medical devices

Benefits

Why This Technique Matters:


  • Reduce risk of device failure and regulatory rejection
  • Support product approval with defensible, compliant test data
  • Improve patient safety and device reliability


Our 3-Step Process to Safer, Compliant Products

From initial consultation to clear, actionable results, we make it simple to get the data you need to move forward.

 

Start with a Discovery
Call

Book a consult with our technical experts

Receive Technical Consultation

We assess compliance requirements, testing scope, and timelines

Get Fast, Accurate Answers

Expert testing and analysis delivered with actionable data

Ready to Get Results You Can Trust?

Book a consult with our team to discuss your goals, get expert input, and map out your next steps — with no pressure, just clarity.