OPED’s Quality Management and Regulatory Affairs (QM&RA) team carried a heavy load maintaining MDR-compliant documentation for many different products and product variants. Relying on Word and Excel meant that each new product version or regulatory update required repetitive edits across multiple files - a process that consumed time, invited errors, and made audits stressful.
By partnering with CertHub, OPED shifts to a data-centric approach where structured data becomes the single source of truth. Documents are now generated automatically and remain consistent across all product lines.
This saves significant time, makes documentation submission-ready at the push of a button, and streamlines the management of multiple product variants.
OPED GmbH develops innovative orthopaedic products and sustainable therapy concepts from its headquarters in Valley, near Munich. With around 400 employees, the company has grown from a small manufactory into a modern medical technology enterprise, fully compliant with the EU Medical Device Regulation. At the heart of OPED’s work is a commitment to patient recovery, customer needs, and environmentally friendly productio
For OPED, keeping MDR Technical Documentation up to date was becoming a time-consuming and resource-heavy task.
The QM&RA team relied on Word and Excel files, copying information across multiple templates. Each new product version or regulatory update meant re-editing the same content in many places - a process prone to errors and hard to audit.
With dozens of products and variants, the workload quickly became unsustainable. OPED wanted a data-centric way to manage the 300+ individual data points that make up a TechDoc, with documents acting as a view, not the primary work product.
OPED partners with us — CertHub, the next-generation Compliance Companion platform — to digitalise their regulatory content.
Together we set up a step-by-step implementation:
- Bi-weekly project meetings with the full OPED team to align the database model, regulatory logic, and next steps.
- 1:1 sessions with Stefan to clarify detailed questions and keep the project moving smoothly.
- A strong foundation was created in CertHub’s Knowledge Model: 73 Knowledge Types, 6 libraries, 17 Knowledge Units, and more than 320 data points already mapped and structured.
With this base in place, OPED can maintain a single source of truth for regulatory data, while CertHub automatically generates fully traceable TechDocs, keeps every update consistent, and ensures documentation is always ready at the push of a button.
OPED GmbH develops innovative orthopaedic products and sustainable therapy concepts from its headquarters in Valley, near Munich. With around 400 employees, the company has grown from a small manufactory into a modern medical technology enterprise, fully compliant with the EU Medical Device Regulation. At the heart of OPED’s work is a commitment to patient recovery, customer needs, and environmentally friendly productio
For OPED, keeping MDR Technical Documentation up to date was becoming a time-consuming and resource-heavy task.
The QM&RA team relied on Word and Excel files, copying information across multiple templates. Each new product version or regulatory update meant re-editing the same content in many places - a process prone to errors and hard to audit.
With dozens of products and variants, the workload quickly became unsustainable. OPED wanted a data-centric way to manage the 300+ individual data points that make up a TechDoc, with documents acting as a view, not the primary work product.
OPED partners with us — CertHub, the next-generation Compliance Companion platform — to digitalise their regulatory content.
Together we set up a step-by-step implementation:
- Bi-weekly project meetings with the full OPED team to align the database model, regulatory logic, and next steps.
- 1:1 sessions with Stefan to clarify detailed questions and keep the project moving smoothly.
- A strong foundation was created in CertHub’s Knowledge Model: 73 Knowledge Types, 6 libraries, 17 Knowledge Units, and more than 320 data points already mapped and structured.
With this base in place, OPED can maintain a single source of truth for regulatory data, while CertHub automatically generates fully traceable TechDocs, keeps every update consistent, and ensures documentation is always ready at the push of a button.
Head of QM & RA
“Seeing all our regulatory information in one model is a big step forward. CertHub lets us focus on data quality instead of formatting dozens of documents. With the analyzer we are always sure that all TechDoc data is correct and completely. Finally the time we save and the ability to handle product families so easily makes a huge difference for our team.”
With its digital foundation secured, OPED is set to expand the use of CertHub across product lines and regulatory activities — strengthening efficiency, compliance, and giving the QM&RA team more freedom to innovate.
A key insight from this transformation is that rethinking Technical Documentation is a continuous process. Throughout implementation, OPED and CertHub found that some traditional sections were unnecessary. This ongoing refinement keeps the data model lean, complete, and truly value-driven.
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