How did Munich Medical Devices reach ISO 13485 audit readiness in 4 months?

CertHub's ISO 13485 process framework came 70 to 80% pre-configured. MMD team adjusted the remaining 20 to 30% to fit their specific implant products. Starting from that base instead of from zero made the difference on a tight timeline.

How does the platform connect lab work to regulatory documentation?

The team executes lab processes and creates the records inside CertHub at the same time. The data feeds into the technical documentation without a separate transfer step. R&D and regulatory stay connected from the start.

Why did Munich Medical Devices implement CertHub from day one?

Before CertHub, the team dealt with hundreds of Word documents and PDFs scattered across subfolders, with no reliable way to find the current version of anything. For a 4-person startup building a complex implant portfolio, that approach was not workable. Starting with the platform immediately meant the team had one place for everything from the first week.

ISO 13485 in 4 Months: Munich Medical Devices

Frequently asked questions

When a 4-person team reaches ISO 13485 audit readiness in 4 months with a technically complex implant portfolio, people want to know how.