OneOrtho Medical, MedTech technology partner
Deploy your personalized surgery platform
As a technology partner to medical device manufacturers, we design and deliver the platform that enables you to deploy personalized surgery, across all surgical specialties.
Certifications and labels
- ISO 13485MDR 2017/745
40 experts by your side
You have a technology and a protocol. We have the platform, the manufacturer status and production facility. Together, your innovation reaches the operating room.
The challenge
Medical device software: the bottleneck isn't the idea, it's the infrastructure and regulatory compliance
Every player seeking to deploy personalized surgery builds the same things, before even the first patient:
- 01
A software infrastructure and 2D / 3D surgical planning tools
- 02
The ability to turn medical imaging into digital twins and orchestrate the digital surgical workflow
- 03
A secure patient data management system
- 04
A Quality Management System, a clinical evaluation and a CE marking technical file
We have already built all of this so we can take charge of your market access.
Explore the platformWork with OneOrtho Medical
Three collaboration models & regulatory support
You choose what you bring and what we take on. In every case, you keep your brand, your data and your intellectual property.
Portfolio Ortho
who integrates
We do
Everything already exists, you deploy it
You access what already exists. Access to the platform and to off-the-shelf orthopedic planners, deployed under your own brand.
Learn moreConnect
Who develops
You
On our platform foundation, with the SDK and APIs
You build, we host. You plug your business modules into our platform. We operate the infrastructure.
Learn moreStudio
Who develops
Us, together
Based on your specifications
We develop together. We design your digital surgical solution from your specifications.
Learn more
Industrialization
Our regulatory support
We take charge of your solution's market access.
Quality Management System, clinical evaluation, validation process, technical documentation and CE marking. Our support can be engaged at any of the three levels above, or on its own. You retain ownership of your technology.
The platform, a single foundation
A platform shared by every surgical specialty
Our expertise: orchestrating the entire digital surgical chain.
Imaging and digital twin
The patient's CT or MRI scan becomes an accurate 3D model, segmented by AI.
2D/3D preoperative planning
The surgeon chooses the implant, its size and its position before entering the operating room.
Patient information
Patient data stays centralized and HDS-hosted, from imaging to follow-up.
Intraoperative guidance
In the operating room, the plan carries on: patient-specific guides or mixed reality.
Postoperative follow-up
Postoperative data is collected on the platform to make follow-up easier.
The foundation
Invisible to the healthcare professionals, decisive for you
- Automation
- HDS-certified infrastructure
- GDPR-compliant
- Cybersecurity
- Documented SDK and APIs
- Ownership of your data
Quality
Regulatory
Notified body
Industrialization
Regulatory support
We carry your market access. Quality file, technical file, CE marking, validation process. Our regulatory support can be activated on any of the three levels above, or on its own. You keep ownership of your technology.
Proof through SURGICAL SPECIALTIES WE SERVE
Your application, in your surgical specialty
Each new specialty is a plug-in on the same foundation: our platform.
Discover the surgeriesWhat sets us apart
Medical device software publisher and certified manufacturer
The combination that lets you deploy personalized surgery with agility. We don't just advise on your market access, we take charge of it.
Software publisher
SaaS platform and surgical planning software
Workflow and health data management
Manufacturer status
ISO 13485 quality system since 2014
More than 20 CE markings obtained since 2015
Software publisher
Digital twins from medical imaging
AI models and anatomical studies
Manufacturer status
Technical files and MDR 2017/745 compliance
Your CE file is built within our scope and can be transferred if needed
Industrial producer
3D printing of custom-made devices since 2017
Integrated ISO 7 cleanroom since 2019
Industrial producer
Intraoperative guides and instruments
Ready-to-sterilize packaging or gamma sterilization
We are not a start-up just getting started
13 years of digital medical devices brought to market
Founded in 2013, part of the MENIX group for 10 years, independent since 2024 and strengthened by the acquisition of Abys Medical in December 2024. We are a 40-person SME, both a software publisher and a medical device manufacturer.
Learn more about OneOrtho Medical
+13 years
of business expertise
+15
manufacturer clients
+17 000
surgeries planned
+500
users
40
experts by your side
Do you have a technology to bring to the operating room?
A one-hour conversation is enough to know whether your project fits Portfolio Ortho, Connect, Studio, or from the standalone regulatory support option..
