Degradation Testing
Medical devices must maintain structural integrity and biocompatibility throughout their intended lifespan. Degradation testing is a critical evaluation process that assesses how medical device materials break down under physiological conditions over time. This testing identifies potential degradation byproducts that could be released into the body, evaluates their biological impact, and ensures device performance remains consistent. Given that degradation can lead to mechanical failure, adverse tissue reactions, or systemic toxicity, comprehensive degradation analysis is essential for regulatory compliance and patient safety. Manufacturers rely on degradation testing to validate product durability, mitigate clinical risks, and meet stringent requirements from global regulatory bodies including the FDA, and EU MDR.
Our Service
Meditronics (a brand of STEMart) provides ISO-compliant degradation testing services for a wide range of medical device materials, ensuring thorough evaluation of their degradation behavior under simulated physiological conditions.
Polymeric Medical Devices
Evaluates hydrolytic, oxidative, and enzymatic degradation mechanisms.
Identifies leachable byproducts (monomers, additives, plasticizers).
Assesses changes in mechanical properties over time.
Ceramic Medical Devices
Analyzes dissolution behavior in simulated body fluids.
Measures ion release and surface stability.
Evaluates long-term structural integrity.
Metallic Implants
Tests corrosion resistance (pitting, crevice, galvanic corrosion).
Quantifies metal ion release (e.g., nickel, chromium, cobalt).
Assesses degradation effects on mechanical strength.
Why Choose Meditronics?
At Meditronics, we specialize in delivering comprehensive degradation testing solutions tailored to medical device manufacturers' unique needs. Our cutting-edge capabilities and regulatory expertise ensure your products meet the highest safety and compliance standards.
✔ Regulatory Compliance Guaranteed
We adhere to ISO 10993, FDA, and EU MDR requirements, streamlining your path to regulatory approval.
✔ Tailored Testing for Every Material
Our customized degradation studies account for device type, material properties, and clinical application, ensuring precise and relevant results.
✔ State-of-the-Art Analytical Methods
Leveraging SEM, FTIR, ICP-MS, HPLC, and mechanical testing, we provide in-depth degradation profiling for accurate risk assessment.
✔ Comprehensive Support from Concept to Compliance
From initial material evaluation to final biocompatibility assessment, we offer end-to-end testing solutions for complete device safety assurance.
By collaborating with Meditronics, you gain a strategic advantage—enhanced product reliability, minimized clinical risks, and accelerated regulatory clearance.
Contact us today to discuss how our degradation testing expertise can support your next medical device innovation.
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