Smithers
Smithers is a leading provider of testing, consulting, and regulatory services for medical devices, including comprehensive biocompatibility testing per ISO 10993 standards. Smithers offers biological safety evaluation services to support FDA, EU MDR, and global regulatory submissions.
Smithers is a global provider of testing, consulting, and regulatory services for medical devices, pharmaceuticals, and consumer products. Smithers provides comprehensive biocompatibility testing services in accordance with ISO 10993 standards, supporting medical device manufacturers in achieving regulatory compliance for FDA, EU MDR, and international markets. The organization offers a complete range of biological safety evaluation services including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-23), systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), hemocompatibility (ISO 10993-4), and pyrogenicity testing. Smithers maintains ISO/IEC 17025 accredited laboratories and GLP-compliant facilities. With decades of experience in medical device testing and regulatory support, Smithers helps clients develop efficient biocompatibility testing strategies and navigate complex regulatory requirements.
About
**Who they are**
Smithers is a leading provider of testing, consulting, and regulatory services for medical devices. They specialize in comprehensive biocompatibility testing, adhering to ISO 10993 standards.
**Expertise & scope**
* Conduct biological safety evaluations to support regulatory submissions for the FDA, EU MDR, and global markets.
* Offer comprehensive biocompatibility testing services.
**Reputation / proof points**
* Established provider of testing, consulting, and regulatory services.
Smithers is a leading provider of testing, consulting, and regulatory services for medical devices. They specialize in comprehensive biocompatibility testing, adhering to ISO 10993 standards.
**Expertise & scope**
* Conduct biological safety evaluations to support regulatory submissions for the FDA, EU MDR, and global markets.
* Offer comprehensive biocompatibility testing services.
**Reputation / proof points**
* Established provider of testing, consulting, and regulatory services.
Additional information
Smithers supports medical device manufacturers in navigating complex regulatory landscapes. Their services are designed to provide the necessary data for biological safety evaluations, crucial for gaining market access. Buyers can expect a structured approach to testing that aligns with international standards, facilitating smoother submission processes. Engagement typically involves detailed project scoping to ensure all regulatory requirements are met.
Key Highlights
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Leading provider of testing, consulting, and regulatory services for medical devices.
Source
“Smithers is a leading provider of testing, consulting, and regulatory services for medical devices”
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Offers comprehensive biocompatibility testing per ISO 10993 standards.
Source
“including comprehensive biocompatibility testing per ISO 10993 standards.”
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Provides biological safety evaluation services to support regulatory submissions.
Source
“Smithers offers biological safety evaluation services to support FDA, EU MDR, and global regulatory submissions.”
Certifications & Trust Signals
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Recognized provider in the medical device testing and regulatory sector.
Source
“Smithers is a leading provider of testing, consulting, and regulatory services for medical devices”
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 biocompatibility testing.
- Companies seeking regulatory support for FDA and EU MDR submissions.
How engagement typically works
- Project-based testing and evaluation.
- Consultative approach to regulatory strategy.
Typical deliverables
- Biological safety evaluation reports.
- Biocompatibility testing data packages.
- Regulatory submission support documentation.
Good to know
- Best when specific ISO 10993 testing protocols are required.
HQ:
Smithers, CA
Languages:
English
Timezones:
PST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Fixed package
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Pyrogenicity
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
In-house toxicology capabilities for biocompatibility testing.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Quote SLA:
24-48 hours
Rush Available:
Yes
Sample Requirements:
Specific sample requirements will be provided upon consultation.
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$25-50k
Regions Served:
Canada, United States
Is Accredited:
Yes
Lead Time Band:
Start in 2-4 weeks
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing, Biological safety evaluation
