AIMDek Technologies- MedTech Verification & Validation Services

MedTech Verification Validation Services

We provide design, software and hardware V&V services for Medical Device, Healthcare Platforms, SaMD and IoMT companies while working in-sync with your product and regulatory teams.

Periodic V&V is a Vital
Compliance Need

As Medical Devices companies keep upgrading themselves to stay relevant, interoperable and a part of a connected care systems, there arises a need for periodic Verification and Validation of your devices to stay aligned with FDA requirements and to ensure that you could validate the purpose, design, security, and outcomes of your medical devices.

AIMDek V&V Services – We
provide you with modern
V&V services with an
assurance of quality!

With comprehensive V&V testing and with the power of automation, we provide our customers with an extended team of V&V experts that provides:

V&V protocols that are designed in sync with your product teams
Test cases that helps with governance and modern validation
Testing accelerators and automation tools that helps identifying gaps in the systems
Enabling interoperability and cybersecurity V&V along with product V&V
Test audits that helps with V&V logs for your regulatory teams

AIMDek’s Customer Centric V&V Process

Our V&V Services

Manual Testing Services

Acceptance Testing
Usability Testing
Formal Validation Testing
Integration Testing
GUI Testing
Functional Testing

Automation Testing

Bug Analysis and Automated triage
Process automation
DevOps integration
Low-code automation
Unified automation solution

Specialized Testing

Computer System Validation
GDPR Testing
Interoperability Testing
Localization Testing
Accessibility Testing
Performance Testing
Security Testing

Go Beyond Conventional Testing With

Simulation Testing

Testing labs play a crucial role in simulation testing, where realistic scenarios are created to mimic various patient conditions. By leveraging sophisticated simulation tools, testing labs can evaluate how the continuous monitoring device performs under different medical scenarios, helping identify and rectify potential issues.

Human Factor Testing

Human factor testing is vital in assessing how well healthcare professionals can interact with the device. Testing labs can simulate user scenarios to ensure that the device’s user interface is intuitive, user-friendly, and supports efficient decision-making during critical situations.

Our Experience Driven V&V Approaches

Collaboration with Regulatory Teams

A seamless collaboration between the testing team and regulatory affairs professionals is paramount. Regular communication ensures that testing efforts align with regulatory requirements and standards. This collaboration includes providing comprehensive documentation for the V&V process and addressing any regulatory concerns.

Collaboration with Product Teams

Close collaboration with product teams is essential for understanding the intricacies of the continuous monitoring device. Testing teams should actively engage in discussions about design specifications, intended use, and any updates to ensure that testing aligns with the product’s intended functionality and user expectations.

Transparent Communication

Maintain transparent communication channels among testing, regulatory, and product teams. Regular meetings and status updates help foster a shared understanding of testing progress, challenges, and potential risks, enabling a proactive approach to problem-solving.

Unique Combination of Manual and Automation Talent

The journey of developing continuous monitoring medical devices requires a holistic approach to V&V testing. By adopting risk-based testing, leveraging real-time testing environments, and incorporating automation tactics, developers can ensure the reliability and regulatory compliance of these critical healthcare technologies.