We are happy to announce that SurgiCube International BV is fullfilling the Quality Management Systems standard ISO 13485:2016 for its organisation. This certificate is provided by the Notified Body Dekra Certification BV. Inspection and audit are carried out on a yearly basis.
Since September 2017 the SurgiCube has been cleared by the FDA according to 510(K).
This means that the SurgiCube can now be marketed in the US for ophthalmic surgery.
We have asked a lot of experts about their opinion on bringing the SurgiCube to the clinic.
First we are proud to show you the interview we had with Dr. Petr Masek from The University Hospital Ostrava.
Download the information here:
As of April we can support our trusted distributors via the SurgiCube Kit on our website.
The SurgiCube Kit maintains all relevant information about the SurgiCube. This information is spread through various folders, brochures and online pages, some of which we use infrequently.
This way it is more easy to convince stakeholders in the hospitals and show them the unique selling points of the SurgiCube.
From now on, it only takes a minute to locate, login, and access all the SurgiCube information.
We are proud of this extra tool and believe it can be helpful for our distributors to promote the SurgiCube.
During this congress in September we promoted the SurgiCube as well as the Operio Mobile and other tools.
Toul Meditech AB is proud to announce that Operio has been cleared by the FDA according to 510(k) and the device can now be marketed in the US. Operio is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery.
We would like to announce that on 1st July 2016 we moved to our new premises – our new contact details are as follows:
SurgiCube International BV
3237 MG Vierpolders
Please note that our telephone number and email address remain the same.
We look forward to continuing our pleasant working relationship from the new address.