Medical Device Testing

Ensuring biocompatibility, material safety, and global compliance.

At IIBAT, we offer comprehensive medical device testing services to support manufacturers in evaluating the biocompatibility, chemical composition, and material safety of their products. Our studies comply with international standards such as ISO 10993, US FDA 21 CFR Part 820, EU MDR, and ISO 13485.

Whether you’re preparing a 510(k) submission, CE marking dossier, or conducting a product redesign, we provide regulatory-grade data that supports market approval and patient safety.

🩺 Why Medical Device Testing is Essential

Medical devices come into contact with the human body—sometimes temporarily, sometimes permanently. Testing is required to demonstrate:

  • Biocompatibility: The material does not cause cytotoxicity, irritation, or sensitisation.
  • Chemical safety: Extractables and leachables do not pose a toxicological risk.
  • Material compliance: Composition, purity, and consistency are verified.

Without this data, regulators cannot verify safety, and market access is delayed or denied.

🧪 Our Medical Device Testing Services

We offer ISO 10993-compliant biocompatibility, chemical characterization, and extractables/leachables testing to evaluate the biological and chemical safety of medical devices. These studies support CE marking, FDA submissions, and global market approvals across device classes.

1. Biocompatibility Testing (ISO 10993 Series)

Objective: Assess how the device or its materials interact with biological systems.

 

Test Types:

  • Cytotoxicity (ISO 10993-5) – In vitro cell viability assays
  • Sensitisation (ISO 10993-10) – Guinea pig maximisation test or LLNA
  • Irritation (ISO 10993-10) – Dermal or mucosal models
  • Acute systemic toxicity (ISO 10993-11)
  • Subacute/Subchronic toxicity
  • Implantation studies (ISO 10993-6) – Local tissue response
  • Hemocompatibility (ISO 10993-4) – Coagulation, hemolysis, complement activation

✅ Conducted per GLP where required
✅ Tailored based on device classification and body contact duration

2. Extractables & Leachables (E&L) Testing

Objective: Identify and quantify potentially harmful substances released from the device under expected use conditions.

 

We offer:

  • Extractables profiling (accelerated solvent extraction with various media)
  • Leachables testing under simulated-use conditions (e.g., saline, ethanol, pH variants)
  • Targeted & non-targeted screening using LC-MS/MS, GC-MS, and ICP-MS
  • Toxicological risk assessment of detected compounds
  • USP <1663>, <1664>, ISO 10993-18, and FDA guidance compliant methods

✅ Essential for drug-device combination products, catheters, implants, and IV systems
✅ Includes toxicologist evaluation and risk characterization reports

3. Chemical Characterization (ISO 10993-18)

Objective: Define the chemical constituents of the device and assess their relevance to patient safety.

Services include:

  • Qualitative and quantitative identification of device materials
  • FTIR, GC-MS, LC-MS/MS, ICP-MS analysis
  • Organic and inorganic profiling
  • Residual monomer and catalyst detection
  • Comparison of test and control batches/materials
  • Justification of equivalence to predicate devices or previous submissions

✅ Often required before biological testing
✅ Supports risk-based approaches to biocompatibility

4. Material & Polymer Testing

Objective: Evaluate material integrity, purity, and consistency.


Our lab supports:

  • Thermal analysis (DSC, TGA)
  • Molecular weight determination (GPC)
  • Spectral analysis (UV-Vis, FTIR, NMR)
  • Mechanical testing (tensile strength, elasticity, hardness)
  • Moisture and residual solvent analysis

✅ Supports incoming material qualification, supplier auditing, and design verification

5. Sterilization Residue Analysis

Objective: Ensure that sterilisation processes do not leave behind harmful residues.

Services include:

  • EO residual analysis (per ISO 10993-7)
  • Radiation effect studies (gamma, e-beam, EtO)
  • Sterile barrier integrity verification

✅ Required for EO-sterilized, gamma-irradiated, and steam-sterilized devices
✅ Critical for packaging validation and shelf-life studies

Why Choose Us?

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Integrated chemical and toxicological risk assessment

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Proven support for CE marking, FDA, and global submissions

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End-to-end medical device testing under one roof