ISAR-M GmbH, a Bavaria-based MedTech innovator, was already ISO 13485 certified when the team decided to move to a more modern, scalable eQMS solution. Their goal: a system that grows with them, supports efficient processes, and reduces administrative overhead. Partnering with CertHub, the migration was completed in only 6 weeks. Throughout the process, CertHub provided close, hands-on support — ensuring a smooth transition from the legacy setup to a more advanced digital platform.
ISAR-M GmbH is developing THYRO®, the world’s first post-operative bleeding detector for thyroid surgery. The device continuously measures compartment pressure to detect internal bleeding early; helping hospitals provide safer, more efficient patient care.
ISAR-M previously operated an ISO 13485-certified QMS on a less flexible eQMS platform and had to temporarily rely on Office-based workflows to remain adaptable. This created a clear need for a modern, easy-to-maintain, and future-proof QMS solution.
CertHub delivered a complete transformation of ISAR-M’s compliance processes in under 2 months: Guided the ISAR-M team step-by-step through migration and system setup Provided fast, personal support for every question and challenge Collaborated closely to resolve technical hurdles in real time Adapted the platform to align with ISAR-M’s specific processes and requirements Enabled AI-powered extraction to instantly convert documents into structured, compliance-ready data in the CertHub format
ISAR-M GmbH is developing THYRO®, the world’s first post-operative bleeding detector for thyroid surgery. The device continuously measures compartment pressure to detect internal bleeding early; helping hospitals provide safer, more efficient patient care.
ISAR-M previously operated an ISO 13485-certified QMS on a less flexible eQMS platform and had to temporarily rely on Office-based workflows to remain adaptable. This created a clear need for a modern, easy-to-maintain, and future-proof QMS solution.
CertHub delivered a complete transformation of ISAR-M’s compliance processes in under 2 months: Guided the ISAR-M team step-by-step through migration and system setup Provided fast, personal support for every question and challenge Collaborated closely to resolve technical hurdles in real time Adapted the platform to align with ISAR-M’s specific processes and requirements Enabled AI-powered extraction to instantly convert documents into structured, compliance-ready data in the CertHub format
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.”
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