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Unlocking the Full Potential of Your Medical Device:

DEVICE

TESTING

Our testing services cover every aspect of the development process, from proof of concept testing to lot release and complaints investigation.  Ensuring your device is safe and reliable.

TESTING

SUPPORT IN..

DIAGNOSTICS

MEDTECH

SaMD

FEMTECH

SURGICAL

COMBO

SCOPE

TESTING

Our team operates within our certified ISO13485 quality management system and cutting-edge testing labs for seamless testing to your product requirements. 

DEVICE CHARACTERISATION

Unveiling Material, Mechanical, & Electrical Excellence:

Understand Material Composition:

  • We perform rigorous tests to reveal the intrinsic properties of the materials used in your device.

Assess Mechanical Integrity:

  • Our mechanical tests evaluate the device's strength and durability under various conditions.

Verify Electrical Safety:

  • We conduct electrical tests to ensure your device operates safely and efficiently.

Achieve Regulatory Compliance:

  • We ensure your device meets all industry standards and regulations for a streamlined approval process.

SOFTWARE TESTING

Reliability, Security, & Compliance in Focus:

Gain Software Reliability:

  • Testing or optimal functionality and reliability, ensuring your software meets industry standards.

Ensure Hardware Integration:

  • Our tests confirm seamless interaction between your software and hardware components.

Fortify Security:

  • Identify vulnerabilities and recommend enhancements to bolster software security.

Achieve Regulatory Compliance:

  • Ensure your software adheres to FDA, ISO, and IEC guidelines for a smooth approval process.

VERIFICATION & VALIDATION

Certifying Performance, Safety, & Compliance:

Confirm Design Specifications:

  • Through verification, we ensure that your device meets all outlined design specifications and functionalities.

Validate Clinical Efficacy:

  • Our validation tests confirm that your device performs as intended in a clinical setting, ensuring safety and effectiveness.

Streamline Regulatory Submissions:

  • We generate comprehensive reports that facilitate smoother regulatory submissions and approvals.

Minimize Risk:

  • Our rigorous testing procedures identify and mitigate potential risks, ensuring a safer and more reliable product

LOT/ BATCH RELEASE

Ensuring Consistency, Quality, & Regulatory Adherence:

Confirm Product Consistency:

  • We perform tests on each lot or batch to ensure uniform quality and performance across your medical devices.

Validate Material & Component Quality:

  • Our rigorous testing verifies that the materials and components in each batch meet specified quality standards.

Facilitate Regulatory Compliance:

  • We conduct tests in line with FDA, ISO, and other relevant guidelines to ensure each batch is compliant and ready for market release.

Accelerate Time-to-Market:

  • Our efficient testing processes and reporting enable quicker lot approvals, helping you get your product to market faster.

Resolving Issues, Ensuring Quality & Building Trust:

Identify Root Causes:

  • We thoroughly investigate each complaint to pinpoint the underlying issue, whether it's a design flaw, manufacturing error, or user misunderstanding.

Implement Corrective Actions:

  • Based on our findings, we recommend and help implement corrective measures to prevent future occurrences of the issue.

Ensure Regulatory Compliance:

  • Our investigation processes are aligned with FDA, ISO, and other regulatory guidelines, aiding in compliance and potential audits.

Enhance Customer Satisfaction:

  • By swiftly and effectively resolving complaints, we help you maintain customer trust and uphold your brand's reputation.

SERVICES

OUR

Comprehensive Testing Support with full service provision for your needs.

Requirement Reviews

Working with your development teams to refine and check the requirements for omissions on testable requirements.

Protocol and method development

Creating bespoke test methods against your established acceptance criteria suitable for intended use.

Test Method Validation

Validation of your or our method to ensure the test is suitable for its intended purpose.

Result Analysis

Reviewing and conducting statistical analysis on data generated as defined within test plans or test methods.

Test plan Generation

Using your requirements to Build verification and validation test suites for your product.

Packaging & Transport Validation

Validation of your primary, secondary and final packaging solution to international standards.

Measurement system analysis

Assessment of any and all measurement systems which may be used in development.

Anomaly Investigation

Conducting engineering investigations into any issues identified during testing.

Test Rig Generation

Creating, designing and validating test rigs for experimental use.

Cleaning & Sterilisation Validation

Working with you to develop and implement robust cleaning and sterilsation validation activites for your device.

Test Execution

Conducting and executing defined tests using our internal labs and technical team. 

Report Generation

Generating development reports for quality review and compliance.

CHAT

LET's

Do you have a testing need?

Drop us an email and let's connect for a virtual coffee.

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