Case Studies

Biological Evaluation Plan (BEP) for a Next-Generation Implantable Device

Developed a risk-based BEP to meet FDA and ISO 10993-1 standards, helping the client avoid delays and save $300K through targeted testing.

When Failed Cytotoxicity Is Not the Whole Story

Chemva’s strategic data interpretation helped the partner avoid unnecessary re-testing and product reformulation

Overcoming Adverse Sensitization Results

Chemva led a contextual data evaluation to assess whether the positive result represented a real clinical risk.

Defending Polymer Stability with Historical Use and Material Science

Chemva led a detailed material-specific risk assessment, supported by both scientific literature and historical clinical use.

Connectors Cracking: A Root Cause Analysis and Material Selection Effort

Chemva’s systematic approach not only resolved the cracking issue but also enhanced the product’s long-term reliability and manufacturability.

Strategic Vendor Selection for Biocompatible Polymers in Inhaler Development

Chemva implemented a multi-step vendor qualification strategy to identify a reliable source of medical-grade polymer materials.

Securing Product Integrity with Reliable Raw Materials Supply

Chemva developed and implemented a risk-based supplier qualification framework

Resolving Unknown Extractables to Enable Pivotal Clinical Study

Chemva swiftly conducted a comprehensive Material Risk Assessment

Proactive Semi-Targeted E&L Strategy for a Polymer-Additive-Based Medical Device

Chemva’s semi-targeted E&L design eliminated potential FDA objections before they could be raised.

Identifying Critical Gaps with E&L Protocol to Ensure Seamless PMA Application

Chemva conducted a comprehensive review of the E&L protocol, evaluating analytical strategies, extraction conditions, and toxicological relevance.

Material Compatibility Assessment for Solvent-Bonded Luer Hub Assembly

Chemva led a material compatibility evaluation using HansenSolubility Parameters (HSP) to scientifically assess the interaction potentialbetween each candidate hub material, the bonding solvent, and the polyurethanetubing.

Assessing the Impact of Antioxidant Reduction in a Container Closure System

Chemva performed a comprehensive risk assessment focused on understanding whether the antioxidant reduction would materially impact the polymer’s performance, stability, or toxicological profile.

Custom Formulating a Non-PTFE Lubricious Coating to Solve Supply Chain Constraints & Incoming Regulations

Leveraging our deep expertise in biocompatible coatings and polymer systems, Chemva led a coating reformulation and optimization program tailored to the device’s surface, application method, and clinical use.

Addressing Carcinogenicity Concerns Without E&L for EU MDR Submission

Chemva proposed and executed a paper-based Material Risk Assessment (MRA) specifically designed to address both genotoxic and non-genotoxic carcinogenicity pathways.

Identifying Formaldehyde Risk Through Material Risk Assessment for a Medical Device

Chemva conducted a systematic, material-specific MRA, analyzing each component and processing additive and manufacturing steps to identify chemical structures or precursors associated with CoCs.

Establishing Material Equivalence After a Raw Material Supplier Manufacturing Site Change

Chemva conducted a comprehensive material equivalency assessment to evaluate potential variations between batches sourced from the original and new manufacturing sites.

Reverse Engineering Competitor Device Materials and Surface Coatings

Chemva designed and executed a custom reverse engineering plan targeting both bulk materials and surface coatings of the competitor’s connector and delivery components.

Avoiding Simulated E&L Testing Through Read-Across Toxicological Risk Assessment

Chemva conducted a comprehensive Toxicological Risk Assessment (TRA) using a read-across strategy, allowing us to bridge data gaps with scientifically valid surrogate information.

In-Silico Genotoxicity Assessment for Drug Packaging-Related Impurities

Chemva performed a tiered in-silico genotoxicity assessment using (Q)SAR tools and expert toxicological interpretation to classify the packaging-derived impurities per ICH M7 guidelines.

Establishing Toxicological/Biological Equivalence After Undisclosed Additive Change in Medical-Grade Resin

Chemva recommended a dual Toxicological Risk Assessment (TRA) strategy, using results from E&L testing