MB Research Laboratories
MB Research Laboratories offers expert biocompatibility testing for medical devices, ensuring compliance with ISO 10993 standards and FDA regulations. They provide tailored testing programs to meet diverse material and format needs, supporting global regulatory submissions.
MB Research Laboratories specializes in comprehensive biocompatibility testing for medical devices, adhering strictly to ISO 10993 standards, FDA regulations, and Good Laboratory Practices (GLPs). Their integrated in vitro and in vivo testing capabilities are designed to accelerate product development and facilitate smoother global regulatory submissions. They offer customized testing programs to evaluate a wide array of biological endpoints, including cytotoxicity, sensitization, irritation, systemic toxicity, and implantation. MB Research can assess various medical device materials such as polymers, metals, ceramics, and biodegradable composites, in formats ranging from raw materials to finished assemblies. With extensive experience supporting FDA submissions and international regulatory dossiers, MB Research ensures that all medical device testing is scientifically rigorous, GLP-compliant, and regulatory-ready. Their expertise covers specific assays like ISO 10993-5 Cytotoxicity and ISO 10993-10 Sensitization, providing critical data for product safety and market approval.
About
**Who they are**
MB Research Laboratories is a provider of expert biocompatibility testing for medical devices, operating in full compliance with ISO 10993 standards, FDA regulations, and Good Laboratory Practices (GLPs). With decades of experience, they support global regulatory submissions and product development.
**Expertise & scope**
* Offers integrated in vitro and in vivo testing capabilities.
* Designs customized testing programs addressing biological endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, and implantation.
* Tests a diverse range of materials including polymers, metals, ceramics, biodegradable composites, and novel substances.
* Accommodates various material formats like scaffolds, coatings, gels, creams, liquids, fabrics, and finished assemblies.
* Provides testing for raw plastic materials (e.g., USP Class I–VI) and fully assembled devices.
* Specializes in regulatory toxicology testing, including OECD and EPA-compliant studies.
* Offers eye and skin safety testing, utilizing in vitro, alternative, and in vivo methods aligned with OECD and ISO standards.
* Conducts skin/dermal sensitization testing using methods like KeratinoSens™, THP-1 cell line (h-CLAT), DPRA, IVSA, and LLNA.
* Performs acute toxicity testing, including the EPA 6-Pack for FIFRA and TSCA compliance.
**Reputation / proof points**
* Over 50 years of experience in eye and dermal hazard identification services.
* Leading the development and promotion of alternative and in vitro assays since 1989.
* Decades of experience supporting FDA submissions and international regulatory dossiers.
MB Research Laboratories is a provider of expert biocompatibility testing for medical devices, operating in full compliance with ISO 10993 standards, FDA regulations, and Good Laboratory Practices (GLPs). With decades of experience, they support global regulatory submissions and product development.
**Expertise & scope**
* Offers integrated in vitro and in vivo testing capabilities.
* Designs customized testing programs addressing biological endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, and implantation.
* Tests a diverse range of materials including polymers, metals, ceramics, biodegradable composites, and novel substances.
* Accommodates various material formats like scaffolds, coatings, gels, creams, liquids, fabrics, and finished assemblies.
* Provides testing for raw plastic materials (e.g., USP Class I–VI) and fully assembled devices.
* Specializes in regulatory toxicology testing, including OECD and EPA-compliant studies.
* Offers eye and skin safety testing, utilizing in vitro, alternative, and in vivo methods aligned with OECD and ISO standards.
* Conducts skin/dermal sensitization testing using methods like KeratinoSens™, THP-1 cell line (h-CLAT), DPRA, IVSA, and LLNA.
* Performs acute toxicity testing, including the EPA 6-Pack for FIFRA and TSCA compliance.
**Reputation / proof points**
* Over 50 years of experience in eye and dermal hazard identification services.
* Leading the development and promotion of alternative and in vitro assays since 1989.
* Decades of experience supporting FDA submissions and international regulatory dossiers.
Additional information
MB Research Laboratories emphasizes scientifically sound, GLP-compliant testing to ensure medical devices are safe and compatible for use in human patients. Their customized testing plans are designed to meet current regulatory expectations for diverse materials and device formats. They leverage both traditional and New Approach Methodologies (NAMs), including in vitro and non-animal testing alternatives, to streamline product development and reduce time to market. Buyers can expect scientifically robust data supporting global regulatory submissions.
Key Highlights
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Offers comprehensive biocompatibility testing for medical devices in compliance with ISO 10993 standards and FDA regulations.
Source
“MB Research Laboratories provides expert biocompatibility testing for medical devices in full compliance with ISO 10993 standards, FDA regulations, and Good Laboratory Practices (GLPs).”
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Designs customized testing programs for a wide range of materials and device formats, from raw plastics to finished assemblies.
Source
“MB Research designs customized testing programs to address the appropriate biological endpoints... Whether you need testing of raw plastic materials (e.g., USP Class I–VI) or a fully assembled device, our scientists can craft a tailored biocompatibility testing plan”
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Leverages decades of experience supporting FDA submissions and international regulatory dossiers.
Source
“With decades of experience supporting FDA submissions and international regulatory dossiers, MB Research ensures that your medical device testing is scientifically sound, GLP-compliant, and regulatory-ready.”
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Specializes in in vitro and alternative testing methods for eye and skin safety, promoting non-animal replacements.
Source
“Since 1989, MB Research has been leading the development and promotion of alternative and in vitro assays, inventing, adopting, and adapting non-animal replacements.”
Certifications & Trust Signals
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Expert GLP Testing Services since 1972.
Source
“Expert GLP Testing Services since 1972”
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Operates in full compliance with Good Laboratory Practices (GLPs).
Source
“MB Research Laboratories provides expert biocompatibility testing for medical devices in full compliance with ISO 10993 standards, FDA regulations, and Good Laboratory Practices (GLPs).”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliance.
- Companies requiring biocompatibility and toxicology testing.
- Clients needing support for FDA and international regulatory submissions.
How engagement typically works
- Project-based testing.
- Customized testing program development.
- GLP-compliant study execution.
Typical deliverables
- Biocompatibility test reports.
- Toxicology study reports.
- Regulatory submission data.
Good to know
- Best when specific biocompatibility or toxicology testing is required for medical devices or chemicals.
HQ:
US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Canada, Europe
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-5, ISO 10993-10
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation
Glp Compliant:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Has In House Toxicology:
Yes
Toxicology Capabilities:
MB Research Laboratories provides expert biocompatibility testing for medical devices in full compliance with ISO 10993 standards, FDA regulations, and Good Laboratory Practices (GLPs). Our integrated in vitro and in vivo testing capabilities help streamline your product development, reduce time to market, and support global regulatory submissions. Biological evaluations are essential for ensuring the safety and compatibility of medical devices used in human patients. ISO 10993 outlines the framework for these assessments based on the nature, duration, and type of device contact. MB Research designs customized testing programs to address the appropriate biological endpoints, from cytotoxicity, sensitization, and irritation, to systemic toxicity, implantation, and more. Medical devices are developed from a diverse range of materials like polymers, metals, ceramics, biodegradable composites, and novel substances, which come in many formats including scaffolds, coatings, gels, creams, liquids, fabrics, and finished assemblies. Whether you need testing of raw plastic materials (e.g., USP Class I–VI) or a fully assembled device, our scientists can craft a tailored biocompatibility testing plan that meets current regulatory expectations. With decades of experience supporting FDA submissions and international regulatory dossiers, MB Research ensures that your medical device testing is scientifically sound, GLP-compliant, and regulatory-ready. This assay tests for biocompatibility. The test article is extracted with DMEM media supplemented with 5% fetal bovine serum and tested on monolayer L929 mouse fibroblast cells based on the current ISO 10993‐5 standard. This protocol is a qualitative test to determine the potential of a test article to produce cytotoxicity. This assay tests for cytotoxicity by indirect contact. This assay is not appropriate for leachables that cannot diffuse through the agar or may react with agar. The test article is laid on an agar layer poured above a monolayer of L929 mouse fibroblast cells based on the current ISO 10993-5 standard. This protocol is a qualitative test to determine the potential of a test article to produce cytotoxicity. This assay tests for the cytotoxic potential of a test article when applied to a monolayer of epidermal keratinocytes or fibroblasts in culture.
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility, Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation, Acute Toxicity, Eye Safety, Skin Safety
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
Custom
Pricing Model
Per project
