QPS Holdings, LLC
★★★★★
2.9
/ 5
•
11 reviews
QPS is a global Contract Research Organization (CRO) providing comprehensive preclinical and clinical research services including biocompatibility testing for medical devices. QPS offers ISO 10993 testing services, toxicology studies, and regulatory support for medical device manufacturers worldwide.
QPS Holdings, LLC is a leading global Contract Research Organization (CRO) with extensive experience in preclinical and clinical research services. QPS provides comprehensive biocompatibility testing services for medical devices in accordance with ISO 10993 standards, supporting FDA, EU MDR, and international regulatory submissions. The organization offers a full range of biological safety evaluation services including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and hemocompatibility testing. QPS maintains GLP-compliant facilities and provides integrated services from test planning through regulatory submission support. With a global presence, QPS serves medical device manufacturers worldwide, offering expertise in both standard and specialized biocompatibility testing programs.
About
**Who they are**
QPS Holdings, LLC is a global Contract Research Organization (CRO) that provides comprehensive preclinical and clinical research services. They specialize in supporting medical device manufacturers worldwide.
**Expertise & scope**
* Biocompatibility testing for medical devices, adhering to ISO 10993 standards.
* Toxicology studies to assess the safety of medical products.
* Regulatory support to help clients navigate compliance requirements.
**Reputation / proof points**
* Global presence as a Contract Research Organization.
QPS Holdings, LLC is a global Contract Research Organization (CRO) that provides comprehensive preclinical and clinical research services. They specialize in supporting medical device manufacturers worldwide.
**Expertise & scope**
* Biocompatibility testing for medical devices, adhering to ISO 10993 standards.
* Toxicology studies to assess the safety of medical products.
* Regulatory support to help clients navigate compliance requirements.
**Reputation / proof points**
* Global presence as a Contract Research Organization.
Additional information
QPS Holdings, LLC focuses on delivering a range of preclinical and clinical research services tailored for the medical device industry. Their expertise in biocompatibility testing, specifically aligned with ISO 10993 guidelines, is crucial for manufacturers seeking to ensure product safety and meet regulatory demands. Beyond testing, they offer toxicology studies and regulatory guidance, providing a holistic support system for clients navigating the complexities of medical device development and market entry. Their services are designed to assist manufacturers in demonstrating the safety and efficacy of their devices to regulatory bodies globally.
Key Highlights
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Global Contract Research Organization (CRO) providing preclinical and clinical research services.
Source
“QPS is a global Contract Research Organization (CRO) providing comprehensive preclinical and clinical research services”
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Specializes in biocompatibility testing for medical devices according to ISO 10993 standards.
Source
“QPS offers ISO 10993 testing services, toxicology studies, and regulatory support for medical device manufacturers worldwide.”
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Offers toxicology studies and regulatory support for medical device manufacturers.
Source
“QPS offers ISO 10993 testing services, toxicology studies, and regulatory support for medical device manufacturers worldwide.”
Certifications & Trust Signals
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Employee-owned staffing and recruiting firm.
Source
“QPS Employment Group is an employee-owned staffing and recruiting firm headquartered in Wisconsin, serving job seekers and employers nationwide.”
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 biocompatibility testing.
- Companies seeking comprehensive preclinical research services.
- Organizations needing regulatory support for medical devices.
How engagement typically works
- Project-based research and testing.
- Collaborative regulatory support.
Typical deliverables
- Biocompatibility test reports (ISO 10993).
- Toxicology study reports.
- Regulatory submission support documentation.
Good to know
- Best when requiring specialized preclinical and regulatory services for medical devices.
HQ:
Brookfield, US
Languages:
English
Timezones:
America/Chicago
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity
Is Accredited:
Yes
Glp Compliant:
Yes
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$25-50k
Has In House Toxicology:
Yes
Toxicology Capabilities:
In-house toxicology services are available, including biocompatibility testing, extractables and leachables, and material characterization.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Regions Served:
North America, Europe, Asia
Sample Requirements:
Samples must be submitted with a completed test request form and relevant documentation, including material composition and intended use.
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing, Toxicology studies
