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 provides expert biocompatibility testing for medical devices, ensuring compliance with ISO 10993 standards and FDA regulations. They operate under Good Laboratory Practices (GLPs) and have decades of experience supporting regulatory submissions.
**Expertise & scope**
* Comprehensive biocompatibility testing for medical devices, including in vitro and in vivo capabilities.
* Customized testing programs to address specific biological endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, and implantation.
* Testing expertise across a wide range of materials (polymers, metals, ceramics, biodegradable composites, novel substances) and formats (scaffolds, coatings, gels, creams, liquids, fabrics, finished assemblies).
* Support for testing raw plastic materials (e.g., USP Class I–VI) and fully assembled devices.
* Regulatory testing services, including assays for eye and skin safety, cytotoxicity, and sensitization.
**Reputation / proof points**
* Decades of experience supporting FDA submissions and international regulatory dossiers.
* GLP-compliant testing.
MB Research Laboratories provides expert biocompatibility testing for medical devices, ensuring compliance with ISO 10993 standards and FDA regulations. They operate under Good Laboratory Practices (GLPs) and have decades of experience supporting regulatory submissions.
**Expertise & scope**
* Comprehensive biocompatibility testing for medical devices, including in vitro and in vivo capabilities.
* Customized testing programs to address specific biological endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, and implantation.
* Testing expertise across a wide range of materials (polymers, metals, ceramics, biodegradable composites, novel substances) and formats (scaffolds, coatings, gels, creams, liquids, fabrics, finished assemblies).
* Support for testing raw plastic materials (e.g., USP Class I–VI) and fully assembled devices.
* Regulatory testing services, including assays for eye and skin safety, cytotoxicity, and sensitization.
**Reputation / proof points**
* Decades of experience supporting FDA submissions and international regulatory dossiers.
* GLP-compliant testing.
Additional information
MB Research Laboratories designs customized testing programs to meet diverse material and format needs, supporting global regulatory submissions. Their services are crucial for ensuring the safety and compatibility of medical devices used in human patients. The ISO 10993 framework guides their assessments based on the nature, duration, and type of device contact. They offer integrated in vitro and in vivo testing capabilities to streamline product development and reduce time to market. Their scientists craft tailored biocompatibility testing plans to meet current regulatory expectations, ensuring scientifically sound, GLP-compliant, and regulatory-ready results.
Key Highlights
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Offers expert biocompatibility testing for medical devices in full 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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Provides customized testing programs for a wide range of materials and device formats.
Source
“MB Research designs customized testing programs to address the appropriate biological endpoints... Medical devices are developed from a diverse range of materials... which come in many formats...”
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Possesses 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.”
Certifications & Trust Signals
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Operates under 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 requiring ISO 10993 compliance testing.
- Companies seeking tailored biocompatibility testing programs for diverse materials and device formats.
- Businesses needing support for global regulatory submissions.
How engagement typically works
- Collaborative program design based on specific device needs.
- GLP-compliant testing execution.
- Support for regulatory dossier preparation.
Typical deliverables
- Biocompatibility test reports.
- Customized testing plans.
- Data supporting regulatory submissions.
Good to know
- Best when requiring expert biocompatibility testing aligned with ISO 10993 and FDA regulations.
HQ:
US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Canada, Europe
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-5, ISO 10993-10
Test Types Offered:
Cytotoxicity, Sensitization, Implantation, Irritation, Systemic toxicity
Glp Compliant:
Yes
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation, 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, Custom
