by nuna.digital

Grand Avenue Software

Offers a quality management software solution for medical device companies, supporting compliance with ISO and FDA standards.

Overview

Grand Avenue Software provides a leading quality management software solution specifically designed for medical product companies. Their electronic Quality Management System (eQMS) is trusted by over 400 MedTech innovators and is purpose-built to support compliance with standards such as ISO 13485:2016, ISO 9001, 21 CFR Part 820, and EU MDR 2017/745.

The software automates essential quality processes, allowing companies to remain audit-ready while focusing on developing life-changing innovations. Grand Avenue's eQMS is modular, enabling businesses to start small and expand as needed, adding features without unnecessary complexity or costs.

A testimonial from Amed Ayubi of Corvent Medical highlights the software's intuitiveness, ease of use, and effectiveness, noting its full compliance with FDA and ISO 13485 requirements in audits.

Grand Avenue also offers resources such as case studies and a newsletter providing monthly MedTech compliance updates, success stories, and live training invitations to over 2,000 subscribers.

Tools

Audit Management

Automates and manages internal, external, and supplier audits for medical device companies, ensuring compliance with FDA and ISO standards while reducing risk.

Authentication Management

Enable single sign-on for secure, simplified access to your eQMS, reducing IT workload and enhancing compliance with centralized control.

Automated CAPA management system for compliance, resolution acceleration, and continuous improvement within a connected platform.

Complaint Handling

Software for managing customer feedback and complaints, offering full visibility and control from intake to resolution for medical device manufacturers.

Facilitates seamless data exchange between systems using expertly designed API solutions for enhanced functionality and streamlined workflows.

Software for MedTech teams to manage product development, maintain real-time design history files, and ensure compliance with regulatory requirements.

Document Control

Automates document control processes to enhance quality oversight, support audit readiness, and ensure compliance with ISO and FDA standards.

Equipment Management

Centralized system for tracking calibration, maintenance, and repair tasks with automated scheduling and alerts to ensure compliance and reduce downtime.

Nonconforming Materials

Identify, track, and resolve nonconformances in the MedTech industry with integrated software ensuring traceability and regulatory confidence.

Requirements Management

Define and track product requirements with full traceability across user needs, design inputs/outputs, and risk controls.

Risk Management

Automates risk management to ensure compliance with ISO standards, offering real-time collaboration and prebuilt FMEA templates.

Supplier Management

Centralizes supplier oversight, ensuring compliance and audit readiness with real-time updates and automated workflows.

Training Assessment

Automates employee training assessments to verify understanding and ensure compliance in MedTech teams.

Training Management

Software to automate employee training, ensure compliance, and enhance training quality with real-time tracking and integration with quality management systems.

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