Medical Device and Combination Drug Delivery Device Testing

Combination products and drug delivery devices continue to expand treatment possibilities across a wide range of therapeutic areas. These innovations also introduce added regulatory scrutiny, particularly around the interaction between the drug and device components. Ensuring the safety, performance, and compliance of these products requires coordinated medical device testing and combination drug/device evaluations that meet FDA and global standards.

BA Sciences supports combination product developers with a full suite of analytical services aligned to regulatory expectations. Our testing capabilities span microbiology, chemistry, and stability, with programs tailored to device type, dosage form, and intended use.

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Drug-Device Testing Capabilities

Extractable and Leachables Testing:

We conduct extractables and leachables (E&L) studies to evaluate interactions between packaging or device materials and drug products. Our E&L capabilities include risk assessment, controlled extraction studies, leachables testing under simulated-use conditions, and toxicological evaluation support.

Biocompatibility Testing Support

We support manufacturers in assessing device safety with test programs designed to meet ISO 10993 standards. These may include chemical characterization, residual analysis, and coordination with external labs for in vivo work.

Stability Studies

We design and manage stability studies for combination drug/device products, with conditions that reflect both pharmaceutical and device-specific considerations. Studies may include container closure integrity testing (CCIT), particulate matter analysis, and dose delivery evaluation.

Microbiology Testing:

  • Bioburden method validation to support sterility assurance level demonstration per ISO 11737
  • Sterility testing
  • Endotoxin (LAL) testing
  • Bioburden testing
  • Bacteriostasis/fungistasis (B/F) testing
  • Antimicrobial effectiveness testing
  • Environmental monitoring and cleanroom validation

Programs are structured to meet relevant USP <71>, <85>, <61>, and <62> requirements, as applicable.

Functional Testing and Dose Accuracy

We perform device-specific evaluations to assess dose uniformity, delivery mechanism integrity, and functional reliability over shelf life. These studies are aligned with compendial methods and regulatory guidance for drug-device combination products.

Why Work with BA Sciences

Combination product testing requires experience across device, drug, and regulatory domains. Our team understands how material compatibility, microbiology, and functional performance intersect in drug-device programs. What we provide:

  • Cross-functional expertise in medical device and combination drug/device testing
  • A single lab for microbiology, chemistry, and stability support
  • Programs aligned with FDA combination product guidance and ISO/ICH standards
  • Defined timelines and direct communication throughout the project

We help ensure your combination product meets regulatory expectations for safety and performance—without unnecessary delays.

Ready to Plan Your Combination Product Testing Program?

Tell us about your next combination drug/device or drug delivery device project. We’ll help build the testing program needed to support compliance and market readiness. Contact us to get started.

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