
A CONSOLIDATED APPROACH TO MEDICAL DEVICE EXTRACTABLES / LEACHABLES WITH INTEGRATED TOXICOLOGICAL EVALUATION IN ACCORDANCE WITH ISO 10993-18:2020 AND ISO 10993-17:2023.
CHEMTox™ IS MEDICAL DEVICE CHEMISTRY & TOXICOLOGY SIMPLIFIED.
How ChemTox™ Works
Phase I - Planning & Review
Estimated TAT: 2 Weeks
Estimated TAT: 2 Weeks

01 - Agree to project scope, develop & document test plan - Client issues Purchase Order.

02 - Submit samples to Groenakker for review.
Phase II - Chemistry Testing
Estimated TAT: 5-6 Weeks
Estimated TAT: 5-6 Weeks

03 - Groenakker reviews samples & completes sample submission form for client review.

04 - Chemistry Testing is performed at ISO 17025 accredited laboratory per Groenakker's test plan & methods.
Phase III - Data Analysis & Toxicological Review
Estimated TAT: 1-2 Weeks
Estimated TAT: 1-2 Weeks

05 - ChemTox® Review of data for EU MDR compounds incl. CMR & Cohort of Concern.

06 - Toxicological Risk Assessment generation - derivation of TDmax, EEDmax and calculation of MOS (ChemTox - Plus - ChemTox Max Only).
Phase IV - Reporting
Estimated TAT: 1 Week
Estimated TAT: 1 Week

07 - Final approved reporting of results to Client.
High-Quality
For toxicological risk evaluation, starting with sound chemical data is critical. Through years of method development and validation work, our partner in chemistry testing provides industry-leading turnaround times while reducing or eliminating unknown compounds. State-of-the-art analytical testing with defined uncertainty factors provides a firm foundation for effective risk assessments & gives clients the confidence needed to support global regulatory submissions.
Intelligent
ChemTox™ leverages deep integrations with our laboratory partner and automated data handling techniques to facilitate thorough and efficient review of identified chemical constituents. By creating bespoke tools, Groenakker enhances the workflow of our DABT-certified toxicologist and provides toxicological risk assessments (TRA) in a fraction of standard industry lead times.
Efficient
ChemTox™ is designed to remove the guesswork and uncertainty from extractable & leachable and provide clients with a clear path to decision-making. Chemical analysis and toxicology are integrated to provide an E&L solution which takes weeks to execute, not many months, with budgetary efficiency in mind. As with all activities at Groenakker, ChemTox moves at the speed of your business.
ChemTox™ Core
An efficiently documented review of chemistry data to support medical device registration in Europe. No frills, no strings attached — the data you need in the manner in which it is needed.
- Chemical analysis utilizing exaggerated extraction protocols
- Heavy Metals, VOC, SVOC, NVOC in three (3) solvents*
- Automated analysis of chemistry data & screening for "Red Flags" associated with the EU MDR, REACH, RoHS, etc.
- Templated Risk Assessment and Chemistry Testing Analysis
- Board Certified Toxicologist (DABT) data review
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
ChemTox™ Plus
For more in-depth reviews and data support. This offering provides comprehensive data analysis, specialist review, extended documentation, and custom support.
- Chemical analysis utilizing exhaustive extraction protocols
- Solvent Compatibility (NVR), Heavy Metals, VOC, SVOC, NVOC in three (3) solvents*
- Automated analysis of chemistry data & screening for "Red Flags"
- Templated Toxicological Risk Assessment and Chemistry Testing Analysis
- Grouping of compounds by family to support further evaluations
- Cursory review of compounds above Toxicological Screening Limit (TSL)
- Board Certified Toxicologist (DABT) data review
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
ChemTox™ Max
Our flagship tier, providing the needed detail to support regulatory review & product safety assessments.
- Chemical analysis utilizing exhaustive extraction protocols
- Solvent Compatibility (NVR), Heavy Metals, VOC, SVOC, NVOC in three (3) solvents*
- Automated analysis of chemistry data & screening for "Red Flags"
- Custom Toxicological Risk Assessment and Chemistry Testing Analysis
- Utilization of QSAR & in Silico techniques to assess compound safety
- Documentation of detailed analysis / TE for up to five (5) compounds above TSL
- Board Certified Toxicologist (DABT) data review
- Audit / Submission Support
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
