Services
Material Support
– Materials Selection per ISO 10993 and EU MDR
– Predicting Materials Performance and Compatibility with other materials and related environments
– Vendor Audit & Product Datasheets review
– Quality Check of Raw Materials
– Material Testing (thermal, MW, and mechanical)
Failure Analysis
– Investigate failure in correlation to five factors: Materials, Design, Processing, Installation, and Product Environment
– Understanding mechanism of the failure (i.e. fatigue, UV effect, deformation, wear)
– Use data of relevant tools for assessments such as DSC, DMA, GPC, FTIR, GC-MS, Tensile/Impact Testing, NMR, and SEM
– Delivering expert recommendation for CAPA
Extractable & Leachable (E&L)
– Reviewing E&L protocols, ensuring compliance with ISO 10993-18, ISO 18562, USP <1663>, and recent regulatory feedbacks
– Solvent selection & screening for medical devices
– Study designs for targeted and non-targeted screening
– E&L studies for medical devices, combination products, and air path devices
Biocompatibility
– Biological evaluation plans per ISO 10993 and ISO 18562 for all medical devices (Class I, II, III; Conventional, combination products, and air path devices)
– Materials Assessment Report per ISO 10993-18 to establish device safety and priori knowledge for E&L studies
– Toxicological risk assessment per ISO 10993-17:2023 to address various biological endpoints
– Biocompatibility evaluation report and gap analysis
– Assessing effect of materials/manufacturing change on biocompatibility per ISO 10993
Materials Change & Production
– Support for manufacturing issues related to, such as, surface contamination, material degradation, curing, cracking
– Alternative materials sourcing and vendor screening
– Alternative materials sourcing
– Establishing quality control systems for raw materials
Liaison with CRO Labs
– We understand communicating with contract research organizations (CRO) can be challenging
– We represent the interest of our clients with CROs, reviewing biological and chemistry protocols and addressing any standard deviations
– We take full control to ensure a seamless process for our client
Customized Training
– Offering on-site and on-line training
– Examples of topics that Chemva has offered training before include:
- Introduction to polymers, thermosets and thermoplastics
- Materials selection
- Material testing and test development
- Failure Analysis
- Introduction to Biocompatibility
- Basics of Toxicological Risk Assessment and Relevant Tools
- Connection between Materials, E&L Chemistry, Biocompatibility, and Toxicology
Expert Witness
– Expert advice and unbiased opinions for legal cases involving chemistry, materials, toxicology, and biocompatibility of medical devices and beauty products
– Experience with a diverse set of medical devices: Class I, II, III; Conventional, combination products, and air path devices
– Experience with a diverse set of materials such as silicones, thermoplastics (PVC, PP, HDPE, and etc.) polyurethanes, epoxies, hydrophobic and hydrophilic coatings, and various adhesives.