Overview

Partner: MedLaunch
Client: Early-stage medical device developer (referred to as the “Startup”)
Challenge: Fragmented document control, non-compliant electronic signatures, lack of a centralized QMS
Solution: The Startup implemented Grand Avenue Software with MedLaunch’s expertise.
Results: The Startup achieved regulatory compliance, streamlined document control, and reduced administrative burden.

Partner Intro: MedLaunch

MedLaunch is a consulting firm specializing in product design, quality assurance, and regulatory compliance for MedTech startups. Founded by industry veterans, MedLaunch helps early-stage companies build scalable and compliant Quality Management Systems (QMS) tailored to their needs.

Client Intro: Fast-Growing MedTech Startup

The client is an innovative MedTech startup bringing new technology to market in a highly regulated industry that requires FDA 21 CFR Part 11 and ISO 13485 compliance. With a focus on rapid development and regulatory approval, they needed a strong foundation for managing quality and compliance as they scaled.

To support their growth, they partnered with MedLaunch to ensure they had the right systems and expertise in place. This collaboration would help them establish a structured approach to quality management while allowing their team to stay focused on innovation.

The Problem: Fragmented and Non-Compliant Systems

Before working with MedLaunch, the startup faced several challenges that made managing quality processes difficult and compliance risky. Without a centralized QMS approach, their workflows were inefficient, and critical documents were scattered across multiple platforms. As they grew, these issues became even more pronounced:

• Scattered Documentation: Important files were stored in Google Drive, emails, and contract manufacturer QMS repositories, making it difficult to track the latest versions.
• Non-Compliant Approvals: Adobe Sign was used for document approvals, but without proper authentication controls, it failed to meet FDA 21 CFR Part 11 and ISO 13485 compliance.
• Lack of Centralized Control: Design history files were fragmented across multiple contract manufacturers, leading to gaps in traceability and quality oversight.
• Bottlenecks in Scaling: As new team members joined, retrieving documents and managing approvals became increasingly time-consuming, slowing product development.

This fragmented approach put the company at risk of non-compliance while creating unnecessary inefficiencies that could delay their go-to-market timeline.

The Solution: Implementing Grand Avenue Software

MedLaunch, already supporting the startup’s quality operations, identified Grand Avenue Software as the ideal eQMS solution due to its:

• Built-in compliance with FDA 21 CFR Part 11 and ISO 13485
• User-friendly interface that mirrors a paper-based system
• Modular structure that allows startups to scale over time
• Affordable pricing compared to rigid enterprise solutions
• Flexible framework that allowed the team to retain existing procedures, forms, and numbering systems

Implementation Approach

To ensure a seamless transition, MedLaunch guided the startup through a structured implementation process, minimizing disruption while maximizing compliance and efficiency:

• System Validation: MedLaunch leveraged Grand Avenue’s validation package to ensure compliance.
• Data Migration: They transitioned documents from Contract Development and Manufacturing Organizations (CDMOs) and Google Drive while maintaining traceability.
• Training & Adoption: MedLaunch utilized Grand Avenue’s training environment to onboard employees without disrupting operations.
• Reuse of Existing Assets: Rather than forcing a complete rebuild, MedLaunch was able to incorporate the client’s existing document templates, numbering schemes, and procedures—ensuring continuity and simplifying change management.

The Results: A Compliant and Efficient QMS

With MedLaunch’s expertise and Grand Avenue Software’s intuitive platform, the startup transformed its fragmented quality processes into a streamlined, compliant system. The impact was significant:

• Faster Compliance: The startup avoided regulatory risks by switching from Adobe Sign to a validated system with built in workflows and Part 11 compliant.
• Centralized Document Control: All critical documents were consolidated into a single QMS approach.
• Reduced Administrative Burden: Employees no longer spent time chasing document access and approvals.

By implementing Grand Avenue Software with MedLaunch’s support, the startup gained a scalable, compliant, and efficient QMS approach—setting them up for long-term success.

Conclusion: The Value of Working with a Partner

For growing MedTech startups, implementing a compliant QMS approach can be a complex and time-consuming challenge. By partnering with MedLaunch, the startup not only avoided regulatory pitfalls but also accelerated adoption with minimal disruption. MedLaunch’s hands-on approach ensured a smooth transition, allowing the team to stay focused on product innovation rather than administrative hurdles.

With Grand Avenue Software’s scalable and intuitive platform in place, the startup is now equipped to manage compliance efficiently and adapt as they grow—without the burden of outdated, fragmented processes.