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Transform legacy or unstructured data into structured, compliant formats.
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About ISAR-M GmbH develops medical technologies that improve patient safety in surgical medicine. Their flagship product, ISAR-M THYRO®, is the world’s first post-operative bleeding detector for thyroid surgery. It continuously monitors compartment pressure in the thyroid region 24–48 hours post-op, enabling earlier detection of bleeding and symptom-free re-operation.
Digitising a Paper-Based QMS in Under 2 Months
About ISAR-M GmbH develops medical technologies that improve patient safety in surgical medicine. Their flagship product, ISAR-M THYRO®, is the world’s first post-operative bleeding detector for thyroid surgery. It continuously monitors compartment pressure in the thyroid region 24–48 hours post-op, enabling earlier detection of bleeding and symptom-free re-operation.
Digitising a Paper-Based QMS in Under 2 Months
ISAR-M initially relied on semi-digital and paper-based processes for managing their ISO 13485 Quality Management System (QMS). They saw the following risks in their current approach:
Manual tracking of document revisions led to version confusion.
Paper-based approvals slowed down compliance cycles and increased efforts for the entire team.
Increasing complexity under MDR necessitated a robust and scalable digital QMS.
Centralize all ISO 13485 QMS documents in a digital repository
Away from document thinking towards thinking in content
Ensure traceable, role-based content and document approval
Accelerate readiness for internal and external audits and MDR conformity
CertHub’s team conducted collaborative workshops to map existing workflows and identify regulatory blind spots. Together, we created a roadmap for a full digital QMS rollout tailored to ISAR-M’s regulatory journey.
Integrated Digital QMS Module for SOPs, work instructions, forms, and audit logs.
Enabled automated version control, qualified e-signatures, and stakeholder-specific permissions.
Activated workflow automation, ensuring time-sensitive tasks (e.g., review reminders) never get missed.
Phased rollout with pilot teams in Quality and R&D.
Hands-on training and access to on-demand help content.
Continuous feedback loops to align digital workflows with ISAR-M’s evolving compliance goals.
CertHub’s team conducted collaborative workshops to map existing workflows and identify regulatory blind spots. Together, we created a roadmap for a full digital QMS rollout tailored to ISAR-M’s regulatory journey.
Integrated Digital QMS Module for SOPs, work instructions, forms, and audit logs.
Enabled automated version control, qualified e-signatures, and stakeholder-specific permissions.
Activated workflow automation, ensuring time-sensitive tasks (e.g., review reminders) never get missed.
Phased rollout with pilot teams in Quality and R&D.
Hands-on training and access to on-demand help content.
Continuous feedback loops to align digital workflows with ISAR-M’s evolving compliance goals.
QMB
“What really stood out for us was how responsive the CertHub team was throughout the whole project. We had quite some time pressure for preparing our QMS for an upcoming audit, they were quick to help and always found a practical solution. It made the whole move to a digital QMS much smoother than we expected. Getting this done in under 2 months was very impressive. We really felt supported every step of the way.”
ISAR-M transformed their static QMS into a dynamic compliance engine.
Automated workflows and audit reduce errors and delays.
CertHub empowered ISAR-M to scale confidently and also preparing the Technical Documentions with the same system
Find out your digital maturity level and see our solutions for you to get next levels real customer stories
Time-consuming, manual processes to find the required information by searching large volume of paper documents.
Hard to trace large volume of documents and keep them secure.
High potential for errors as the entries are purely in written form.
Difficulty in organizing and finding documents in the folders.
Lack of version control and data consistency.
No centralized workflow for managing documentation with your existing tools.
Manual effort to manage approvals and track changes.
Potential for human error when managing compliance documents.
Manual effort to manage approvals and track changes. Potential for human error when managing compliance documents. Lack of real-time document collaboration and tracking.
Complex data management.
Ensuring consistency and accuracy across all documentation.
Staying compliant with fast-changing regulations.
We start by reviewing your current state and defining requirements. 🕒 Approx. 1 week
We set up your environment, create templates, and train your team. 🕒 Approx. 1 day setup + 1 week training + 2 weeks configuration
While you start working with CertHub, we help with any questions and provide continuous guidance. 🕒 Integration: 2 weeks + ongoing support
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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