The molecular weight distribution of polymers directly affects the strength, durability, and performance of medical devices. Accurate analysis ensures polymers meet design requirements and maintain stability throughout their lifecycle. Invision Biomedical provides molecular weight distribution testing that validates polymer performance and regulatory compliance.
Applications & Methods
Gel Permeation Chromatography (GPC) Analysis
Measures molecular weight and distribution with high accuracy.
Polymer Stability Assessments
Evaluates material performance under simulated long-term conditions.
Performance Impact Analysis
Assesses how molecular weight variations influence device function.
Regulatory Compliance Assurance
Results align with FDA and ISO expectations for polymer-based medical devices.
Frequently Asked Questions
Why analyze molecular weight distribution?
Polymer characteristics determine durability, stability, and clinical performance.
What methods are used for polymer analysis?
Gel permeation chromatography (GPC) and related methods deliver precise measurements.
How does molecular weight affect device performance?
Testing involves exposing device materials to extraction solvents under controlled conditions. Extracted compounds are analyzed using advanced techniques such as mass spectrometry and compared against toxicological thresholds to assess safety.
How does Invision Biomedical provide reliable results?
Through validated polymer testing and clear reporting tailored for regulatory submissions.
Validate Your Polymer Materials with Confidence
Ensure stability and compliance with precise molecular weight analysis.
