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Medical Devices Testing and Certification Company | Ensuring Safety, Compliance & Performance

In the ever-evolving healthcare industry, the reliability, safety, and compliance of medical devices are critical to patient care and global market access. At Inspectra Edge, we are a trusted medical devices testing and certification company offering end-to-end services for healthcare device inspection, regulatory compliance, and product performance validation.

From surgical instrument testing to electronic medical system testing, our ISO/IEC 17025-accredited labs and expert engineers help you meet the highest standards in safety, functionality, and international compliance. Whether you're launching a new product, upgrading an existing device, or navigating FDA/CE requirements, we’re your partner in delivering trusted medical technology.

Our Responsibility

Healthcare Device Inspection Services for Safety and Functionality

We provide comprehensive healthcare device inspection services to verify product integrity, usability, and manufacturing consistency before market release or distribution. Our inspection capabilities include:

Visual and Dimensional Inspection for surgical instruments and consumables
Component Integrity Checks for plastics, metals, sensors, and connectors
Cleanroom Compliance and Packaging Integrity Review
Sterilization Validation and Shelf-Life Inspection
Documentation Review for Regulatory Submissions
 

Medical Device Quality Assurance Solutions

Our quality assurance solutions are designed to streamline your device lifecycle from prototype to post-market surveillance. We support with:

 

Quality Management System (QMS) review per ISO 13485

 

Risk Management Analysis in line with ISO 14971

 

Device Classification and Gap Assessment for FDA/CE/IVDR

 

Supplier Audits and Component Traceability Review

 

Functional validation of end-user performance

Medical Device Compliance Testing for Global Markets

Gain approval and access to regulated markets with our medical device compliance testing services tailored for US FDA, EU MDR/IVDR, and other international frameworks. Our Compliance services include:

  • Biocompatibility Testing (ISO 10993 series)
  • Electrical Safety Testing (IEC 60601 family)
  • Electromagnetic Compatibility (EMC) and Wireless Testing
  • Usability Engineering and Human Factors Validation
  • Mechanical and Drop Impact Testing for transport safety

Medical Device Performance Testing

Ensure your device performs safely and reliably under real-world conditions with our advanced medical device performance testing services.

  • Functional endurance and stress testing
  • Flow rate, accuracy, and leak testing for infusion and diagnostic devices
  • Battery life and power system validation for portable devices
  • Calibration and sensor accuracy for monitors and electronic health equipment
  • Real-time simulations for clinical environment usage

Specialized Testing for Healthcare Devices

Our specialized lab network supports a range of medical and healthcare device categories:

  • Surgical Instrument Testing – Sharpness, corrosion resistance, material durability
  • Electronic Medical System Testing – Circuit safety, data integrity, connectivity performance
  • Diagnostic Equipment Testing – Calibration, accuracy, and response time validation
  • In Vitro Diagnostic (IVD) Devices – Sample processing validation and reagent stability
  • Wearable and Connected Medical Devices – Wireless connectivity, battery safety, and performance consistency

Why Choose Inspectra Edge for Medical Device Testing?

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ISO/IEC 17025-accredited labs and global compliance expertise

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Full lifecycle testing from prototyping to post-market surveillance

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Experts in CE marking, FDA 510(k) submissions, and IVDR conformity

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Real-time test dashboards and digital certificate delivery

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Trusted by OEMs, startups, and contract manufacturers worldwide

Get a Quote for Medical Device Testing & Certification Services

Whether you need regulatory testing, performance validation, or healthcare device certification, Inspectra Edge ensures your medical devices meet the highest standards of quality, safety, and compliance.

Start Testing Today

Frequently Asked Questions (FAQ)

A: We test surgical tools, diagnostic equipment, IVDs, electronic systems, wearable devices, and implantable technologies.

A: Our testing complies with ISO 13485, ISO 10993, IEC 60601, ISO 14971, FDA 21 CFR, and EU MDR/IVDR frameworks.

A: Yes, we provide testing, documentation, and certification support for both CE marking and FDA 510(k) submissions.

A: Absolutely. We offer performance validation, stress testing, biocompatibility, EMC, and electrical safety under one program.

A: It involves checking the safety, functionality, accuracy, and electrical stability of digital healthcare and monitoring devices.
Inspectra Edge is here to provide confidence and assurance, enabling your business to thrive in a competitive and ever-changing world. Partner with us today and experience the Inspectra Edge difference.
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Inspectra Edge