Development

Development Support for Patient-Centric Medical Devices

Our model provides medical device companies with flexible, scalable, and cost-effective access to specialised testing and development services.

With our support, companies can ensure their products are developed, tested, and monitored to the highest standards, facilitating market success and compliance with regulatory requirements.

Our structured approach can significantly accelerate your product development process, ensuring that every aspect of testing—from early feasibility studies to thorough validation—is conducted with the utmost efficiency and expertise.

Whether you're looking to expand your testing capabilities, reduce development costs, or speed up your time-to-market, our outsourced testing solutions are designed to align with your specific needs and goals.

ASSESSMENT

We begin with a thorough assessment of your current testing processes, identifying areas where outsourcing can offer the most significant benefits.

This step involves evaluating your testing requirements, timelines, and resource constraints to determine where external expertise can fill gaps, enhance efficiency, and reduce costs.

INTEGRATION

Integration involves establishing clear communication channels, setting expectations, and ensuring we fully understand your product, quality standards, and compliance requirements.

Effective integration ensures that the outsourced testing services work seamlessly with your in-house processes, maintaining consistent quality and avoiding any disruption to your development timelines.

OPTIMISATION

As your testing partner, we focus on continuous optimisation.

This involves regularly reviewing testing outcomes, assessing the efficiency and effectiveness of our services, and making adjustments as necessary to enhance product quality and speed to market.

Rigorous Testing Capabilities for Next-Level Medical Devices

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Ensuring Safety, Efficacy, and Market Success with Tailored Testing Services. Our team operates within our certified ISO 13485 quality management system and cutting-edge testing labs, providing seamless testing to meet your product requirements.

DEVICE CHARACTERISATION

Unveiling Your Device - From 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 for 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.

FEASIBILITY TESTING

Pioneering Your Device's Journey - Assessing Viability with Precision and Insight

Evaluate Concept Potential:

We conduct thorough feasibility tests to assess the practicality and potential success of your device concept in real-world applications.

Analyse Technical Viability:

Our technical evaluations delve into the feasibility of your device design, focusing on innovative solutions and potential challenges in development.

Determine Market Readiness:

We explore market trends and demand to gauge the readiness and potential reception of your device within targeted healthcare segments.

Facilitate Strategic Decision-Making:

Our insights empower you to make informed strategic decisions, aligning your device's development path with market needs and regulatory expectations for optimal success.

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.

Minimise Risk:

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

COMPLAINT INVESTIGATION

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.

LOT/ BATCH RELEASE

Ensuring Consistency, Quality, & Regulatory Adherence:

Confirm Product Consistency:

We perform testing 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.