Success story · Startup

QMS migration. Done in 6 weeks.

ISAR-M GmbH already held ISO 13485 certification when they decided to move their QMS to CertHub. Their previous platform was rigid and hard to adapt. CertHub completed the full migration in 6 weeks, without interrupting compliance work.

Full QMS migration in 6 weeks

THYRO® · Surgical Monitoring · ISO 13485

About ISAR-M

A MedTech startup building the first device of its kind

ISAR-M GmbH is developing THYRO®, the world's first post-operative bleeding detector for thyroid surgery. The device continuously monitors compartment pressure to detect internal bleeding early, giving hospitals a faster and safer way to respond.

Based in Bavaria, the team operates under ISO 13485.

Industry

Surgical Monitoring

Headquarters

Bavaria

Regulation

ISO 13485

The challenge

Certified, but stuck on the wrong platform.

ISAR-M's QMS was ISO 13485 certified, but the platform didn't adapt to how the team worked. They had started filling gaps with Word and Excel to stay flexible. The system was compliant, but hard to maintain and impossible to scale.

Before CertHub

QMS on a rigid platform that didn't adapt to their processes.

Word and Excel workarounds to fill platform gaps.

Administrative overhead growing with every change.

Hard to maintain and future-proof as the company grew.

With CertHub

Modern, flexible QMS live in 6 weeks.

AI extraction structured existing documents automatically.

Platform configured to fit ISAR-M's actual workflows.

ISO 13485 certification maintained throughout.

How CertHub helped

A full migration, not just a new tool.

CertHub ran the migration alongside the ISAR-M team. Existing processes, documents, and records moved into a structured digital QMS. Every technical hurdle was resolved in real time.

Migrated the QMS

CertHub guided the ISAR-M team through every step of setup and migration, resolving technical questions in real time.

Adapted the platform

The system was configured to fit ISAR-M's specific processes and regulatory requirements. Not a standard template.

AI-extracted the documents

Existing compliance documents were converted into structured, CertHub-ready data automatically. No manual re-entry.

The result

ISAR-M's QMS is fully live on CertHub. Processes, records, and documents in one place. ISO 13485 certification maintained throughout the migration.

weeks to full QMS migration

platform for QMS, processes, and records

Olivia Fedunik-Brehm

CEO at ISAR-M GmbH

We felt supported every step of the way. Especially the responsiveness and commitment of the CertHub team really stood out. They always found a way to help us move forward.

Start with a QMS that scales.

ISAR-M moved from a legacy platform to CertHub in 6 weeks. Book a call to see how the migration works.

Explore Technical Documentation Book a demo

Questions about QMS migration

How long does a QMS migration to CertHub take?

Will we lose ISO 13485 certification during the migration?

How does CertHub handle documents from our existing QMS?

What does the migration process actually involve?

We're a small team. Can we handle a migration without slowing down product development?