SGS Health Sciences
★★★★★
2.3
/ 5
•
16 reviews
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 to support regulatory submissions.
**Expertise & scope**
* Conducts biocompatibility testing per ISO 10993 standards.
* Provides biological safety evaluation services.
* Supports regulatory submissions for FDA, EU MDR, and global markets.
**Reputation / proof points**
* Leading provider of testing, inspection, and certification services for medical devices.
SGS Health Sciences is a provider of testing, inspection, and certification services for medical devices. They offer comprehensive biocompatibility testing services to support regulatory submissions.
**Expertise & scope**
* Conducts biocompatibility testing per ISO 10993 standards.
* Provides biological safety evaluation services.
* Supports regulatory submissions for FDA, EU MDR, and global markets.
**Reputation / proof points**
* Leading provider of testing, inspection, and certification services for medical devices.
Additional information
SGS Health Sciences focuses on supporting medical device manufacturers in navigating complex regulatory landscapes. Their services are designed to ensure that devices meet the stringent safety requirements mandated by authorities such as the FDA and for compliance with EU MDR. By offering detailed biological safety evaluations, they help clients demonstrate the safety of their products for patient use, thereby facilitating smoother market entry and ongoing compliance.
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 to support regulatory submissions.
Source
“biological safety evaluation services to support FDA, EU MDR, and global regulatory submissions”
Buyer Snapshot
Best for
- Medical device manufacturers seeking biocompatibility testing
- Companies preparing for FDA or EU MDR submissions
How engagement typically works
- Project-based testing services
- Consultative support for regulatory submissions
Typical deliverables
- Biocompatibility test reports
- Biological safety evaluation summaries
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, Biological safety evaluation
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
