St. Jude Medical CRMD
St. Jude Medical CRMD offers sterilization and microbiology testing services for medical devices. Access detailed recall and safety alert data.
St. Jude Medical CRMD is a provider of sterilization and microbiology testing services, crucial for ensuring the safety and efficacy of medical devices. Their expertise supports compliance and risk management within the medical device industry. The International Medical Devices Database, accessible via the provided website, offers extensive information on over 120,000 recalls, safety alerts, and field safety notices. This resource allows users to explore connections between medical devices and their manufacturers, aiding in due diligence and market understanding. The database is a product of a significant global investigation into the harm caused by inadequately tested medical devices.
About
**Who they are**
St. Jude Medical CRMD is a provider specializing in sterilization and microbiology testing services for medical devices. They offer access to detailed recall and safety alert data.
**Expertise & scope**
- Sterilization testing
- Microbiology testing
- Access to recall and safety alert data for medical devices
St. Jude Medical CRMD is a provider specializing in sterilization and microbiology testing services for medical devices. They offer access to detailed recall and safety alert data.
**Expertise & scope**
- Sterilization testing
- Microbiology testing
- Access to recall and safety alert data for medical devices
Additional information
When engaging St. Jude Medical CRMD, buyers can expect a focus on providing essential data for medical device compliance. The services are geared towards ensuring that medical devices meet necessary sterilization and microbiological standards. Access to recall and safety alert information is a key component of their offering, aiding in ongoing product stewardship and risk management.
Key Highlights
Certifications & Trust Signals
-
Founded in 2000.
Source
“Founded in 2000”
Buyer Snapshot
Best for
- Medical device manufacturers requiring sterilization and microbiology testing
- Companies needing access to medical device recall and safety alert data
How engagement typically works
- Service-based engagement for testing needs
- Information access for compliance and safety data
Typical deliverables
- Sterilization testing reports
- Microbiology testing reports
- Recall and safety alert data summaries
Good to know
- Best when specific testing protocols or data access are the primary requirements.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States
Industries:
Medical Devices
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat)
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11135 (EtO), ISO 17665 (Steam), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO (Ethylene Oxide), Steam (Moist Heat), Gamma Radiation, E-Beam, X-Ray, Plasma, Vaporized Hydrogen Peroxide, Other
Validation Types Offered
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring, Other
Lead Time Band
Start in 0-2 weeks, Start in 2-4 weeks, Start in 4-8 weeks, Start in 8-12 weeks, Start in 12+ weeks
Quote SLA
< 24 hours, 24-48 hours, 3-5 business days, 1-2 weeks
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
<$10k, $10-25k, $25-50k, $50k+, No minimum
Pricing Model
Per project, Fixed package, Tiered, Custom
