Why Test Medical Devices?
Medical devices play a critical role in patient safety and healthcare outcomes. Even a minor failure in material quality, cleanliness, or sterility can cause serious harm, trigger product recalls, and erode brand trust.
Without proper testing, you risk:
- Patient injuries or compromised treatment outcomes
- Regulatory non-compliance and delayed approvals
- Costly recalls, penalties, and reputational damage
- Loss of market access due to failed certifications or audits
Regular Medical Device Testing Helps You Ensure:
Regular Medical Device Testing Helps You Ensure:
- Device safety, accuracy, and reliability in real-world use
- Early detection of wear, faults, or contamination to prevent failures
- Compliance with ISO 13485, FDA, EU MDR, BIS, and CDSCO standards
- Long-term trust with healthcare providers and end users
Types of Medical Device Testing We Provide
Biocompatibility Testing
Why : To ensure device materials are safe for human use.
What we test : Cytotoxicity, irritation, sensitization, hemocompatibility, systemic toxicity.
Who needs it : Implantable and non implantable device manufacturers.
Cleaning Validation
Why : Residual contaminants can cause infections or device failure.
What we test : Residual protein, endotoxins, detergents, microbial residues.
Who needs it : Reusable medical devices, surgical instruments, endoscopes.
Sterility & Microbial Testing
Why : Devices must remain sterile until point of use.
What we test : Sterility assurance, bacterial endotoxins, bioburden testing.
Who needs it : Single use devices, sterile packaging, surgical kits.
Physical & Mechanical Testing
Why : Devices must perform as intended under stress and usage.
What we test : Tensile strength, durability, functionality, packaging integrity.
Who needs it : Consumables, implants, surgical tools, diagnostic devices.
Chemical Characterization
Why : To identify harmful chemicals that may migrate from device materials.
What we test : Volatile/semivolatile organics, heavy metals, residual solvents.
Who needs it : Plastic, polymer, and coated medical devices.
Benefits of Testing with Prewel Labs
Compliance Simplified
Meet ISO 10993, ISO 13485, FDA, EU MDR, BIS, and CDSCO requirements.
Digital Dashboard
Real time results, audit ready reports, and AI foresight.
Risk Prevention
Detect issues early before they reach patients.
Global Readiness
Testing aligned with international regulatory expectations.
Brand Protection
Demonstrate safety and earn trust with regulators &
clinicians.
Who We Serve
Medical Device Manufacturers
Implants, surgical instruments, consumables
Diagnostic Companies
Devices, kits, and testing consumables
Hospitals & Healthcare Providers
Cleaning validation for reusable instruments
Exporters & Global Med Tech Firms
Compliance for FDA, EU MDR, and WHO markets
Medical Device Testing at a Glance
| Test Type | Why It Matters | Key Parameters | Who Needs It |
|---|---|---|---|
| Biocompatibility | Ensures device material safety | Cytotoxicity, sensitization, hemocompatibility | Implant & non implant device makers |
| Cleaning Validation | Prevents infections, ensures safe reuse | Residual protein, endotoxins, microbial residues | Hospitals, reusable device makers |
| Sterility & Microbial | Maintains sterility & patient safety | Sterility assurance, endotoxins, bioburden | Single use device manufacturers |
| Physical & Mechanical | Confirms performance & durability | Tensile strength, packaging integrity | Implants, surgical tools, consumables |
| Chemical Characterization | Detects harmful extractables/leachables | Organics, metals, solvents | Polymer/plastic based devices |
FAQs
What are Medical Device Testing Services, and why do I need them in Bangalore?
Medical Device Testing Services in Bangalore, provided by Prewellabs, ensure the safety and effectiveness of your medical devices. Ensure compliance with regulations and enhance product quality by choosing Prewellabs.
How can I request Medical Device Testing Services in Bangalore from PrewelLabs?
To request our services, simply visit our website, prewellabs.com, and fill out our easy-to-use contact form. Our team will get in touch with you promptly to discuss your specific needs.
What types of Medical Device Testing Services does Prewellabs offer in Bangalore?
We offer a comprehensive range of Medical Device Testing Services in Bangalore, including biocompatibility testing, electrical safety testing, performance testing, and more. Contact us today.
Can I get a customized testing plan for my medical device at Prewellabs in Bangalore?
Absolutely! We offer tailored testing plans to meet your device’s unique requirements. Contact us today to discuss your specific needs, and our experts will design a personalized testing strategy.