Comprehensive Materials Testing and Analytical Services at Materials Metric

Materials Metric logo featuring scientific instruments and analytical testing elements, emphasizing quality, compliance & innovation in product analysis.
Menu
Generic selectors
Exact matches only
Search for your required testing or Service
Search for your required testing or Service
Post Type Selectors
page
post

In-Vivo Testing (Implantation & Systemic Toxicity)

In-Vivo testing evaluate the biological response to materials, devices, or coatings within a living system, providing definitive evidence of local tissue compatibility, systemic toxicity, inflammatory response, biodegradation, healing, and long-term integration. These analysis capture complex biological interactions that cannot be fully replicated in vitro, making them essential for implantable, absorbable, and long-term contact products.

At Materials Metric, in-vivo implantation and systemic toxicity studies are designed to align with ISO 10993-6, ISO 10993-11, USP, and FDA expectations, generating clinically relevant safety and performance data that support product development, biological risk assessment, and regulatory submissions.

Uses of In-Vivo Studies

• Assess local tissue compatibility, irritation, fibrosis, or inflammation
• Evaluate systemic toxicity following material exposure
• Examine biodegradation and resorption behavior of absorbable materials
• Validate implant–tissue integration and stability
• Support FDA submissions for implants, resorbables, and long-term devices
• Investigate unexpected responses from earlier in-vitro or chemical tests

In-Vivo Studies (Implantation & Systemic Toxicity)
In-Vivo Studies (Implantation & Systemic Toxicity)

Applications

• Orthopedic and dental implants
• Absorbable biomaterials and scaffolds
• Coatings and drug-eluting systems
• Vascular and cardiac devices
• Catheters, sensors, and long-term implants
• Tissue-contacting polymers, hydrogels, elastomers
• Wound healing, regenerative, and reconstructive materials

Sample Analysis Process

1. Study Design

  • Selection of implantation site (subcutaneous, intramuscular, bone, vascular, or tissue-specific)
  • Determination of exposure duration (acute, sub-chronic, chronic)
  • Definition of biological endpoints based on device classification

2. Implantation & Monitoring

  • Surgical placement following standardized guidance
  • Monitoring for systemic toxicity, behavioral changes, and local reaction
  • Collection of tissues, fluids, and organs for analysis

3. Endpoint Evaluations

  • Histopathology for inflammation, fibrosis, necrosis, and healing
  • Local effects scoring per ISO 10993-6
  • Systemic toxicity per ISO 10993-11
  • Biodegradation assessment for absorbable devices
  • Implant–tissue interface analysis

4. Data Analysis & Reporting

  • High-resolution pathology images
  • Quantitative scoring of tissue reactions
  • Evaluation of systemic organ pathology
  • Degradation and absorption profiles
  • Full ISO-aligned interpretations and regulatory justification
In-vivo study at Materials Metric

Why Choose Materials Metric for In-Vivo Studies

Materials Metric provides scientifically rigorous, regulator-aligned in-vivo biocompatibility studies backed by deep expertise in biomaterials, toxicology, and biological safety.

We offer:

• ISO 10993-6 & 10993-11 Compliant Study Designs

Studies structured to meet FDA, EU MDR, PMA, and global regulatory expectations.

• ISO 9001:2015 Accredited Workflows

Every step follows strict quality standards, ensuring reproducibility, traceability, and audit-ready study execution.

• Expert Histopathology & Biological Interpretation

Interpretation from experienced biomaterials scientists who clarify why tissue responses occur—not just what is observed.

• Integrated Chemical + Biological Insight

In-vivo responses are correlated with:
• chemical characterization
• extractables/leachables
• surface chemistry
• microstructure & coatings
• mechanical behavior

This provides a complete understanding of material–tissue interactions.

• Submission-Ready Documentation

Reports formatted for smooth inclusion in 510(k), PMA, De Novo, and ISO 10993 Biological Evaluation Plans.

Materials Metric ensures your in-vivo data is scientifically sound, defensible, and aligned with regulatory pathways, reducing risk and expediting approval.

Related services 

To learn more about our In-Vivo Testing or other testing needs, please contact us.


Frequently Asked Questions

What are in-vivo studies for implantation, systemic toxicity, and local biological effects?

These in-vivo studies evaluate how a material behaves in a living system, covering local tissue response at an implantation site and systemic effects of exposure. They are used when in-vitro and chemical data are insufficient to conclude biological safety. Materials Metric scopes these within an ISO 10993 biological evaluation.

What endpoints do these in-vivo studies measure?

Implantation studies assess the local tissue reaction to a material over defined time points, while systemic toxicity studies assess whole-body effects from material exposure. Endpoints include local inflammatory and histological response and systemic clinical, biochemical, and pathology measures. Results inform the overall biological safety conclusion.

What sample is required for these in-vivo studies?

Provide the material in final, processed, and sterilized form, or representative extracts for systemic studies, in sufficient quantity for all test groups, time points, and controls. Disclose composition, intended contact, and duration. Final-form, clinically representative articles are required.

Which standards apply to these in-vivo studies?

Implantation studies are commonly performed in line with ISO 10993-6 and systemic toxicity in line with ISO 10993-11, within the overall ISO 10993 biological evaluation and using validated or fit-for-purpose methods. The specific design reflects the device contact category and duration. The method basis is documented.
Scroll to Top