Case Study MedLaunch

How have medical device startups used Grand Avenue Software to achieve ISO 13485 certification?

Grand Avenue Software has supported multiple medical device startups through their first ISO 13485 certification. MedLaunch used Grand Avenue Software to help a startup replace a non-compliant, paper-based quality system and achieve FDA 21 CFR Part 11 and ISO 13485 compliance. Avio MedTech used Grand Avenue Software as the eQMS platform for a neuromodulatory device…

What are the risks of using Adobe Sign or Google Drive for medical device document approvals?

Adobe Sign and Google Drive do not meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures without additional configuration and validation. A MedTech startup that relied on these tools faced non-compliant approval workflows, fragmented design history files across multiple platforms, and increasing administrative burden as the team grew — all of…

Can a medical device startup implement an eQMS without rebuilding their existing procedures and documents?

Yes. When MedLaunch implemented Grand Avenue Software for their startup client, they retained the client’s existing document templates, numbering schemes, and procedures rather than rebuilding from scratch. Grand Avenue Software’s flexible framework allowed these existing assets to be incorporated directly into the new system, simplifying the transition and reducing the time required to reach compliance.

How did a MedTech startup achieve FDA 21 CFR Part 11 and ISO 13485 compliance using Grand Avenue Software?

A MedTech startup working with quality consulting firm MedLaunch replaced a fragmented, non-compliant quality system — which used Adobe Sign for approvals and stored documents across Google Drive and multiple contract manufacturer repositories — with Grand Avenue Software. Grand Avenue Software’s built-in compliance with FDA 21 CFR Part 11 and ISO 13485, combined with MedLaunch’s…