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 focused on Biocompatibility Testing (ISO 10993).
**Expertise & scope**
* Expertise in Biocompatibility Testing according to ISO 10993 standards.
* Services encompass a range of tests to assess the biological safety of medical devices and materials.
**Reputation / proof points**
* The provider is associated with Rutgers New Jersey Medical School, which focuses on advanced biomedical research and medical education, emphasizing innovation and community service.
SGS Health Sciences is a provider focused on Biocompatibility Testing (ISO 10993).
**Expertise & scope**
* Expertise in Biocompatibility Testing according to ISO 10993 standards.
* Services encompass a range of tests to assess the biological safety of medical devices and materials.
**Reputation / proof points**
* The provider is associated with Rutgers New Jersey Medical School, which focuses on advanced biomedical research and medical education, emphasizing innovation and community service.
Additional information
When engaging SGS Health Sciences for Biocompatibility Testing, buyers should be aware of the specific scope of ISO 10993 standards they support. The provider's description indicates a connection to a medical school, suggesting a strong foundation in biomedical research. Buyers should clarify the exact testing methodologies and the specific ISO 10993 sub-parts covered to ensure alignment with their product's regulatory requirements. Understanding the typical lead times and quote turnaround is also crucial for project planning.
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 biocompatibility testing.
- Companies seeking to ensure the biological safety of their products.
How engagement typically works
- Project-based testing.
- Consultation on biocompatibility strategies.
Typical deliverables
- Biocompatibility test reports.
- Data supporting regulatory submissions.
Good to know
- Best when specific ISO 10993 standards are clearly defined by the buyer.
- Requires clear communication regarding sample submission and testing timelines.
HQ:
Newark, US
Languages:
English
Timezones:
EST
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, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Hemocompatibility, Pyrogenicity
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 expertise for risk assessment and biological safety evaluation
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Regions Served:
United States, Europe, Asia, Canada
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)
