GIVE YOUR DEVICE A HEALTHY START

Analytical Chemistry for Preclinical Medical Device and Combination Product Development

Industry-leading analytical chemistry testing with proprietary methods of screening for a variety of compounds — guaranteeing the high level of quality you expect.

Tests designed by our specialists with a custom approach, keeping regulatory requirement criteria in mind

Studies conducted with proprietary methods of screening for the high level of quality you expect

We pursue the answers you need to provide clarity throughout the entire preclinical testing process

What is analytical chemistry in medical device development?

Understanding the chemical makeup of your device or combination product and its effect on the body is an important component of your product’s preclinical testing. Every medical device program needs to evaluate the materials that have direct or indirect bodily contact and meet regulatory standards using standardized analytical chemistry methodologies.

We conduct all of our analytical chemistry studies using proprietary methods of screening or a variety of compounds—providing the high level of quality you expect.

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You have complex questions about your device. We’ve got answers.

Whether your device is simple or complex in nature, we partner with you to establish the best plan and study needed for achieving regulatory approval. Our deep experience in analytical chemistry includes:

Extractables and leachables (E&L)
Manufacturing residual testing
Dose verification and validation
Storage and stability testing
A wide array of validation methods

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Analytical Chemistry Solutions

Our vast portfolio of analytical chemistry testing services has you covered in whatever you need:

E&L and risk assessment: ISO 10993 (Part 18)

Extractable evaluation using model solvents
Validated screening methods
Various techniques: ICP/MS, GC/MS, LC/MS and LC/HRAM
Method development/validation for target compounds from device or in-drug product
Simulation study of medical devices
Leachable analysis in drug product

Compendial and ancillary tests

Pharmacopoeias (USP, EP, JP) (e.g., USP <661>, USP <661.1>, USP <661.2>, USP <381>, RP 3.2.2.1, EP 3.3.4)

Biological Safety Evaluation Plan per ISO 10993-1
Food compliance testing (e.g., U.S.: FDA 21 CFR 177.XXXX series)
Ethylene oxide residual analysis: ISO 10993 (Part 7)
Raw material qualification (FTIR)
Plasticizer analysis (16 e.g., phthalates, DEHP, BPA, TOTM)
Nitrosamines analysis (nine compounds)
BPA analysis
Miscellaneous instrument analysis (GC, ICP-OES, ICP/MS, GC/FID, GC/MS, LC/MS, HRAM-LC/MS, UV-Vis, FTIR, etc.)
HPLC analysis: lot release, target analysis, dose analysis
Particle size analysis: light obscuration USP <788>
Accelerated aging and stability testing
Analytical method development and validation
Dose verification
Cleaning validation and sample analysis (e.g., heart valve rinse/extraction analysis for glutaraldehyde, gasoline range organics [GRO] profile)
Elution studies (e.g., nickel, copper)

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By the Numbers

~6,000

preclinical medical device studies conducted per year

150+

highly experienced preclinical medical device specialists

10+

average years of experience per specialist

We know that your medical device or combination product has the potential to bring greater outcomes to patients in need. That’s why we share your urgency to advance your medical devices and combination products. Whatever your goals and milestones, we’ll help you reach them on time. From developing clear road maps to communicating proactively, we work with speed and efficiency at every turn to keep pace with your important milestones.

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Together, we can give your device a healthy start. Let’s start the conversation.