Frequently Asked Questions

Is Customize a segmentation software?

Yes, Customize is the backbone for the patient-specific field. Customize is a web-based platform accessible by your team and your customers. It starts from the Dicom reception (web upload) to the post-marketing surveillance. It structures the full process and integrates the information in one place. In the segmentation step, you can use the integrated segmentation tool or use your own software. We also have AI-based segmentation for specific applications.

What can I expect from Customize?

You will focus your attention on what is important. All the process is under control. You follow your step by step approach, described in your ISO. No waste of time in emails, reports, live web meeting, traceability reports, dashboard management, etc… so it is faster for everyone. 10 times faster in terms of completion time to fulfill a case. That is our result at 3D-Side. Moreover, you have your own branded platform and full access to all your customers. That is a powerful marketing tool. And a unique customer experience.

How many licenses do I need?

Only one.

Is there a limit to the number of users?

No! unlimited, simple, and efficient. No need to plan the number of licenses according to the demand.

What about GDPR?

The platform allows to work with an ID (UDI) for each case. This automatically produced UDI will be used in all documents, communication, … ensuring traceability while complying with the GDPR. However, you can tune the system to put minimum information to allows the hospital to identify the patient and reach the correct operating theatre.

Can I use the software for maxilla facial surgery planning?

Yes. Customize is an open platform. You can set up various workflows for various kinds of patient-specific devices.

Can I use the software for orthotics?

Yes, also. The design step is different. You can use your own software and push the STLstl in the platform or ask us to develop a web-based tool to fully integrate the process.

Do I have to change my segmentation software?

No, it is not mandatory. You can still use your segmentation (or design) software. Depending on the number of cases you have to process, we can help you in the automatization of the segmentation (AI) and design of the device, integrated in our software in that case. You can then integrate Customize step by step for your quality system.

How to send an e-mail to the surgeon?

Via the platform. You have access to a tool to send e-mail to the customer and you can set up templates to speed up the process. The template will be automatically filled with data available in the platform (for example patient ID, surgery date, …). In your workflow, when you enter a step which requires sending an e-mail, it will be charged automatically… you just have to select the appropriate language and click “send”.

What about the MDR?

The MDR is a major change for all medical companies. For medical software also as their classification will be stricter in the MDR (no more a class I). Customize is already a Class IIa software. So, no problem with the upcoming MDR.

How can I adapt the medical report or the IFU produced by the software?

You have access to all templates. Actually, your templates. You can edit them in HTML and adapt the information for all upcoming cases or for a specific case only.

The software seems fully integrated. Do I have to buy all the modules?

No, but some of them are mandatory (Supervise - Interact). Additional features can then be selected (production, advanced interactions,..)

What about certification EU/USA?

We have both certifications. Check with our team as certification must be checked according to the medical application.

Can I have my logo on the main page?

Yes, this is your platform. A parametrization will take place to set up your branding but also first workflows, todo lists,…

Can I have a trial version?

Unfortunately, no. The platform MUST be parametrized to your application. As already mentioned, the workflow, the templates of reports, IFU, e-mails, … But also, the access to a secured server, rights, training, … This is not a one-fits-all software as it allows to automatize various tasks.

But of course, our team is available for an advanced demo and we can set up a test to give you the opportunity to experience the surgeon access.

Why a web-based software?

To allow/offer easy access, anywhere, any time. For your team but also for the surgeon. It means no software to install on a specific computer inside the hospital.

Is it an advantage if my team is homeworking?

Definitely! Your team can work remotely while ensuring full traceability and access to all the data. You can also easily control the production level, deadlines,…

My process/workflow is very specific. Can I adapt the software to my way of working?

Yes. Do not hesitate to contact us to evaluate your needs.  

Regarding the ISO and the change in my internal process, what will be the impact?

The main validations can be maintained with the platform. A lot of tasks will be automated, but the information will still be available. Of course, an internal validation will be required, as for any software used in an ISO 13485 environment. Audits will be much easier as all the information of a case will be easily accessible. Including post-marketing surveillance, if you use that option.

Can the user visualize the pre-op and post-op conditions of an anatomy with an implant overlay?

Yes. The 2D images or 3D models coming from the preop acquisition are available for viewing. The post-op 3D models can be shown in separate viewers or overlapped within the same viewer. Customize is fully versatile, the Interact module can display any available information.

 

Miscellaneous

3D-Side is privately held by strong investors active in the medical and software fields. 3D-Side has the capability to grow and to invest to ensure performance and efficiency for our customers.

3D-Side SA, headquartered in Belgium is proud to announce the opening of 3D-Side Inc to support the commercialization of 3D-Side’s products and ensure the best quality of service to its customers.

Our ISO13485:2016 ensures high performance of products but also for software. The developments are controlled by our notified body and built on an efficient backbone allowing 3D-Side to dedicate and parametrize its software to our customer specifications.  

3D-Side’s team is composed of PhDs, engineers with expertise in software, mechanical engineering, and quality.

 

3D-Side is also surrounded by experts in regulatory (EU and FDA), Artificial intelligence, and UX experience.

 

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3D-Side’s mission is to help our clients contribute to the United Nation sustainable goals (Goal 3. Target 3.4) by providing them Customize

SDG 3.4: “By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being”

André Dumont, 5
1435, Mont-Saint-Guibert
Belgium