Heavy Metals Analysis

Heavy metals such as lead, cadmium, and arsenic can leach from medical device materials, posing serious toxicological risks. Regulatory agencies require precise detection and quantification to ensure patient safety and biocompatibility. At Invision Biomedical, we provide sensitive and accurate heavy metals testing aligned with ISO 10993 and FDA requirements, delivering data you can trust for submissions and risk assessments.

Applications & Methods

Trace Element Detection

Using ICP-MS and other advanced methods, we detect trace metals at extremely low concentrations.

Regulatory Threshold Comparison

Results are evaluated against FDA and ISO biocompatibility standards to ensure compliance.

Root Cause Investigation

Analysis helps identify the origin of metal presence, whether from materials, coatings, or manufacturing processes.

Risk Assessment for Biocompatibility

Our studies provide toxicological relevance, helping clients evaluate potential patient exposure risks.

Frequently Asked Questions

Why test for heavy metals in medical devices?

Even at low levels, heavy metals can pose health risks, making detection essential for safety and compliance.

Which metals are most commonly monitored?

Nickel, lead, cadmium, arsenic, mercury, and chromium are among the most frequently tested.

What analytical methods are used?

ICP-MS, atomic absorption, and related techniques provide precise quantification of metals at trace levels.

How does Invision Biomedical provide regulatory-ready results?

We use validated methods, deliver clear reporting, and align data packages with FDA and ISO submission needs.

Ensure Patient Safety with Heavy Metals Testing

Detect, quantify, and mitigate heavy metals risks with confidence.