Providing Quality Chemical Characterization So You Can Improve Quality of Life

How Safe Is My Device?

Accurate extractables analysis of medical devices, coupled with toxicological risk assessment, can save time, money, and minimize risk when bringing your product to market. However, recent changes in ISO 10993-18:2020 have made conducting a chemical risk assessment even more challenging than ever before.

When Do I Need a Chemical Risk Assessment?

  • According to ISO 10993-1:2018, chemical risk assessment is the first step in performing a biocompatibility assessment.

  • As part of FDA submissions such as Investigational Device Exemption (IDE), 510(K) Premarket Notification, Premarket Approval (PMA).

  • The EU MDR has similar requirements for chemical risk assessment.

  • To evaluate a new material of composition or contact material as being chemically equivalent to an “old” material.

  • As a guideline for internal Quality Control.

Chemical Risk Assessment Workflow

The chemical risk assessment workflow may be viewed as a three-tiered structure composed of:

Click on elements above for more information

Please contact us for more information on how we can assist in evaluating your devices to the new ISO 10993-18:2020 standard and workflows.