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 in accordance with ISO 10993 standards.
**Expertise & scope**
* Provide biological safety evaluation services to support regulatory submissions for the FDA, EU MDR, and global markets.
* Offer comprehensive biocompatibility testing per ISO 10993 standards.
**Reputation / proof points**
* Founded in 1919 (implied by Smithers general company information, not specific to this division, use with caution if not explicitly stated for this service line)
Smithers is a leading provider of testing, consulting, and regulatory services for medical devices. They specialize in comprehensive biocompatibility testing in accordance with ISO 10993 standards.
**Expertise & scope**
* Provide biological safety evaluation services to support regulatory submissions for the FDA, EU MDR, and global markets.
* Offer comprehensive biocompatibility testing per ISO 10993 standards.
**Reputation / proof points**
* Founded in 1919 (implied by Smithers general company information, not specific to this division, use with caution if not explicitly stated for this service line)
Additional information
Smithers supports regulatory submissions by offering biological safety evaluation services. Their expertise in ISO 10993 testing helps clients navigate complex requirements for medical devices. This includes a range of tests designed to assess the safety of materials that come into contact with the human body, ensuring compliance with global regulatory bodies.
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, including comprehensive biocompatibility testing per ISO 10993 standards.”
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Offers comprehensive biocompatibility testing per ISO 10993 standards.
Source
“Smithers is a leading provider of testing, consulting, and regulatory services for medical devices, including comprehensive biocompatibility testing per ISO 10993 standards.”
-
Provides biological safety evaluation services to support FDA, EU MDR, and global 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 seeking ISO 10993 biocompatibility testing.
- Companies requiring support for FDA and EU MDR regulatory submissions.
How engagement typically works
- Project-based testing.
- Consultative support for regulatory pathways.
Typical deliverables
- Biocompatibility test reports.
- Biological safety evaluation summaries.
- Regulatory submission support documentation.
Good to know
- Best when specific ISO 10993 testing is required for medical device clearance.
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
