Material compliance

Frequently changing substance regulations pose great challenges for plastics processors and medical technology companies. Gradical supports your company in finding its way through the jungle of regulations.

In this area, we offer the following services:

  • Compliance check

  • Compliance Statements

  • Biocompatibility Check

  • Biocompatibility Test Strategy

  • Project Management for Biocomp Testing

Compliance check

Do your customers routinely request regulatory compliance information that you are unfamiliar with? Do you lack the resources or expertise to respond to these inquiries promptly and competently? Gradical can assist you with material compliance reviews. If you wish, we can ask your suppliers directly and obtain the necessary confirmations to answer your customer inquiries. We support you with substance regulations such as:
– REACH / SVHC, Annex XIV and XVII
– RoHS
– California Proposition 65
– TSCA
and many more.

Compliance Statements

Whether simple compliance statements or entire product stewardship booklets; Gradical creates professional and accurate compliance statements for your customer inquiries.

Compliance Statements

Whether simple compliance statements or entire product stewardship booklets; Gradical creates professional and accurate compliance statements for your customer inquiries.

Biocompatibility Check

Are you unsure about the biocompatibility aspects of the plastics you use? Gradical will obtain the necessary confirmations from your suppliers for you and commission the initial material characterizations in order to create the basis for your biocompatibility assessment.

Biocompatibility Test Strategy

Does the intended use of your medical device require biocompatibility testing? Gradical supports your company in developing test strategies and finding suitable test laboratories. We also prepare biocompatibility documentation for you and create or improve your biological risk assessment process. Our Gradical experts can cover all common biocompatibility standards:
– ISO 10993-ff
– ISO 18562-ff
– USP <87>
– USP <88>

Project Management für Biocomp Testing

Testing for biocompatibility is often a lengthy process and involves a great deal of coordination. Our Gradical experts take over the project management for you and minimize your project risk.