ISO 10993-18: Variability in Medical Devices

ISO 10993-18: Variability in Medical Devices

Image Credit: Jordi Labs

Over the last 15 years, ISO 10993-18 has become a notable resource for professionals at each stage in the supply chain and manufacturing of medical devices, assisting them in the evaluation of chemical risk related to their products.

This whitepaper from Jordi Labs outlines the latest updates to ISO 10993-18, which describe how to account for variability in measurement procedures.

If any queries are not addressed in the whitepaper, please contact a member of the Jordi Labs team today. Its knowledgeable team of PhD chemists have considerable experience in regulatory testing in line with ISO standards, and would be happy to assist with queries.

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About Jordi Labs

Jordi Labs provides the highest quality contract analytical services and polymer HPLC columns to some of the world’s leading consumer products, polymers, pharmaceutical and medical device manufacturers. Our team of PhD analytical chemists specialize in chemical identification. One of core competencies is Extractables & Leachables testing.

We are also worldwide leaders in;

  • Particulates & residue analysis
  • Good-bad comparisons
  • Method development/validation
  • Polymer analysis
  • Polymer failure

We also help companies from Fortune 500s to innovative startups with method development, preparative HPLC, training seminars, depositions and consulting. As a family company, we take pride in the production of all of our products and analytical service offerings. It is our goal to help our customers overcome their analytical challenges by providing excellent products and personal assistance from our highly-trained staff of PhD chemists.


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Last updated: Oct 1, 2020 at 5:10 AM

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