Select Projects

Medical Device Biocompatibility Approval:  For a variety of devices, developed customized testing strategies and provided consulting support throughout the entire biological evaluation process to support compliance with the requirements of ISO 10993/18562, US FDA, and the European Union Medical Device Regulation (EU MDR).  Leveraging existing data whenever possible, produced gap assessments and biological evaluation plans/reports that attributed to successful device approvals.

Medical Device Toxicological Risk Assessment:  For a variety of devices and in accordance with ISO 10993-17 and US FDA guidance, identified toxicological data for relevant endpoints and derived chemical- and device-specific safety margins.  For data gaps, identified robust read-across and used state-of-the-art modeling programs to assess potential hazards.  For large datasets, identified efficient and defensible approaches to narrow the scope, and produced clinically relevant toxicological risk assessments.  Our reports assisted in the US FDA and EU MDR product approvals.

Toxicological Hazard Evaluation, SDS, and Labeling:  Managed a large team of human health/ecological toxicologists and chemists to provide GHS hazard evaluations of thousands of chemicals.  Identified appropriate read-across in the absence of toxicological data.  The hazard evaluations were used for compliant SDSs in North America, Europe, Asia, Australia, etc.  Spearheaded the database automation of product-level hazard classifications.  Collaborated with an external IT firm to expand the client’s existing chemical compliance database by automating TSCA reporting requirements.

Alternative Assessment for 6PPD:  Conducted alternative assessment (AA) for 6PPD in motor vehicle tires under California’s Safer Consumer Products (SCP) Program.  Working with a consortium, identified and evaluated potential alternatives to prioritized chemical, aiming to identify safer alternatives.  Gradient’s evaluation was submitted and accepted by regulators.

Merger and Acquisition:  During an environmental due diligence for a buyer, confirmed known details, uncovered potential deal-breaking issues, and assessed level of effort for post-integration work.  Our findings informed the representation and warranty insurance for this acquisition, and our client carved out an area that we identified as problematic.