How We Helped A Biotech Manufacturer to Meet ISO-13485 Standards

In highly regulated industries like biotech and pharmaceuticals, quality control isn’t just a nice-to-have — it’s a mandate. For one of our clients, staying compliant with ISO-13485 meant they needed more than just a basic CRM ticketing system. They needed a process that was accurate, trackable, and automated.

In Episode 4 of Not Your Grandfather’s CRM, we highlight a custom complaint management system we built using Microsoft Power Apps. Designed specifically for ISO-13485 compliance, this tool automatically calculates business-day timelines, tracks issue resolutions, and manages QA handoffs — all with smart alerts and minimal manual effort.

The client can dynamically configure issue types and associated questions, send automated emails to customers and internal teams, track RMAs, and document every step of the resolution process — all in one centralized system. Plus, the dashboard flags anything that’s past its SLA so nothing falls through the cracks.

Do you want an xRM solution that works like it was made for your business? Schedule a Strategy Session with us today.