SGS Health Sciences
SGS Health Sciences is a leading provider of testing, inspection, and certification services for medical devices, including comprehensive biocompatibility testing per ISO 10993 standards. SGS offers biological safety evaluation services to support FDA, EU MDR, and global regulatory submissions.
SGS Health Sciences is a global leader in testing, inspection, and certification services for the medical device industry. SGS 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. SGS maintains ISO/IEC 17025 accredited laboratories and GLP-compliant facilities worldwide. With extensive experience in medical device testing and regulatory support, SGS helps clients navigate complex biocompatibility requirements efficiently and cost-effectively.
About
**Who they are**
SGS Health Sciences is a provider of testing, inspection, and certification services for medical devices. They offer comprehensive biocompatibility testing services that align with ISO 10993 standards.
**Expertise & scope**
* Biological safety evaluation services to support regulatory submissions for the FDA, EU MDR, and global markets.
* Testing services specifically for biocompatibility according to ISO 10993 standards.
**Reputation / proof points**
* Services support FDA, EU MDR, and global regulatory submissions.
SGS Health Sciences is a provider of testing, inspection, and certification services for medical devices. They offer comprehensive biocompatibility testing services that align with ISO 10993 standards.
**Expertise & scope**
* Biological safety evaluation services to support regulatory submissions for the FDA, EU MDR, and global markets.
* Testing services specifically for biocompatibility according to ISO 10993 standards.
**Reputation / proof points**
* Services support FDA, EU MDR, and global regulatory submissions.
Additional information
SGS Health Sciences focuses on providing essential biological safety evaluation services. Their expertise in biocompatibility testing, particularly under ISO 10993, is crucial for medical device manufacturers navigating complex regulatory landscapes. They aim to facilitate smoother submissions to authorities like the FDA and for EU MDR compliance. Buyers can expect a structured approach to testing that generates data necessary for demonstrating device safety to regulators.
Key Highlights
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Offers comprehensive biocompatibility testing per ISO 10993 standards.
Source
“comprehensive biocompatibility testing per ISO 10993 standards”
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Provides biological safety evaluation services for regulatory submissions.
Source
“biological safety evaluation services to support FDA, EU MDR, and global regulatory submissions”
Certifications & Trust Signals
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SGS Health Sciences is a leading provider of testing, inspection, and certification services.
Source
“SGS Health Sciences is a leading provider of testing, inspection, and certification services”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 biocompatibility testing.
- Companies preparing FDA or EU MDR regulatory submissions.
How engagement typically works
- Project-based testing services.
- Support for regulatory compliance.
Typical deliverables
- Biocompatibility test reports.
- Biological safety evaluation data.
Good to know
- Best when specific ISO 10993 testing is required for regulatory approval.
HQ:
Newark, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Canada, Italy, Japan, Denmark, Europe, Asia
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Biodegradation
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Is Accredited:
Yes
Toxicology Capabilities:
In-house toxicology services for biocompatibility testing.
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Regions Served:
United States, Europe, Asia, Canada
Nda Support:
No
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
