Your True Partner from Ideation to Post-Launch
01
Product Development (R&D): Materials Selection & Vendors Screening
– Working with 100s of materials, we help you choose the right material, in compliance with ISO 10993 and EU MDR, for ideal performance, aging, and sterilization profile
– Formulating medical-grade custom adhesives and coatings
02
Extractable & Leachable (E&L): Study design and solvent selection
– Targeted and non-targeted chemical characterization E&L studies per ISO 10993-18 and USP <1663>
– Medical devices and combination products
03
Biocompatibility: Planning & Reporting
– Biological evaluation plans per ISO 10993 & ISO 18562
– Materials Assessment Report per ISO 10993-18
– Toxicological risk assessment per ISO 10993-17:2023
– Biocompatibility evaluation report and gap analysis
04
Manufacturing: Process & Raw Materials
– Alternative materials sourcing
– Materials/manufacturing change & biocompatibility assessment per ISO 10993 & ISO 18562
– Establishing quality control systems for raw materials
05
Post-Market Evaluations: Failure and root cause analysis
Completed over 60 product complaints, determined root cause (i.e. materials variability, improper material selection, use environment, clinician off-label use), and recommended remedies for CAPA
Why Chemva?
20+ Years of Diverse Experience
Experienced Liaison with regulatory agencies (i.e. FDA) and research labs
Experience with various devices: Class I-III. Limited to long-term/implan. Conventional, combination, and air path devices.
Applied Knowledge for Medical Devices
Mix chemistry, materials/polymer science, and toxicology for medical devices
For our clients, this means saving time/cost and avoid major issues with our unique knowledge of materials, toxicology, and biocompatibility
Reliability & Dependability
We accommodate urgent requests and all projects sizes – small or large.
Visiting clients’ sites and visiting labs for our clients.
On-budget and on-time delivery.
Well-recognized Expertise
We co-chair AAMI BE/WG 02 – Degradation Aspects Related to Biological Testing Working Group for developing ISO 10993 standard.
We also have voting rights for AAMI ISO 10993 medical devices standards (TC 194 – WGs 1, 2, 11, 14, & 18), allowing us to prepare our clients for potential future regulatory requirements.
100% of our clients recommend us for quality and expertise.