Technology partner for medical imaging and intelligence

QUALITY POLICY

To be a Trusted Technology Partner and make Universal Access to Medical Imaging and Intelligence.

To create global scale solution, having functionality with 3rd party integrations.
To increase the number of national E-Health systems within our global scale solution.
To create a value added service on top of healthcare imaging and diagnostics.
To ensure a unique position for the opportunities of E-Health and AI.
To provide wider access to medical imaging from anywhere and from any device by different groups: patients, clinicians, insurance, etc.

To be the best Employer in Lithuania.

To ensure justice and respect.
To create workplaces where employees feel respected and important.
To ensure realization and growth of potential.
To link salary growth to the success of the company.

The Main Softneta Value is Respect. Respect for clients and Respect between Employees.

Implementing a quality management system, conforming to ISO 13485 standard, we take care of its effectiveness, ensure compliance with legal and other requirements. We are flexible due to the context of a constantly changing environment, always evaluating the achievements while reviewing policies and objectives. Our workers participate in quality-management processes. They are constantly informed about the organization’s intentions.

CERTIFICATIONS & REGISTRATIONS

IHE (XDS-I.b) profile support

Cross-enterprise Document Sharing for Imaging IHE (XDS-I.b) profile as DOCUMENT CONSUMER (ITI-18, ITI-43, RAD-16, RAD-55, RAD-69 transactions).

FDA Cleared K222320

MedDream is FDA cleared for diagnostic use including mammographic images. FDA 510(k) clearance for MedDream as a Class II medical device. Read more about MedDream FDA clearance: Establishment Registration & Device Listing, 510(k) Premarket Notification, FDA Indications for Use.

CE Class IIb certified

The medical device software MedDream is certified as IIB class medical device according the MDR. Medical software MedDream is now intended to aid in diagnosis by visualization various medical images, video and signals, measuring data in DICOM images and management DICOM images, when the patient is not in life-threatening state of health, time is not critical for medical decision and no major therapeutic interventions are required.

MHRA registration in UK

The MHRA of United Kingdom, a Medicines & Healthcare products Regulatory Agency, has registered the medical software MedDream as IIB class radiology picture archiving and communication system workstation.

Switzerland Class IIB registration

The Swissmedic, a Swiss Agency for Therapeutic Products, has registered the medical software MedDream as a IIB class radiology picture archiving and communication system workstation in Switzerland.

Thailand FDA Certified

Food and Drug Administration of Thailand issued the Sales Certificate S13-18 for MedDream according to the Medical Device Act 1988. The Certificate allows to import MedDream as a medical equipment in Thailand market (valid until 2024-06-10).

Singapore Class B registration

Meddream is registered as Class B medical device by Singapore Medical Device Register (SMDR). Meddream as medical device registration No: DE0504088.

Russia Class 2b registration

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) of Russia, a federal executive body responsible for control and supervision of the healthcare system, has registered the medical software MedDream as a Class 2b medical device.

ISO 13485:2016

Softneta has been found to conform to the quality management system standard ISO 13485:2016
Softneta management system is certified for development and maintenance of software for medical purposes.

EU PROJECTS & FUNDING

“Intelligence LT” for creating an innovative product: Medical Video Router;
“New Opportunities” for export expansion and partners network extension;
The Nordic-Baltic Mobility and Network Programme for Business and Industry to initiate cooperation between Baltic and Scandinavian countries, two times. Gateway Project for export expansion, three times;
For the project “Technical Feasibility Study of the Medical Diagnostic Images Data Bank”;
For the project “Technical Feasibility Study of the Medical Diagnostic Imaging Workstation”;
Reinforcement of competitiveness under the notified measure “New Opportunities LT”;
R&D project of medical operating system and applications under the notified measure “Intelligence. Joint business-science projects”;
R&D project of medical image processing, computer aided diagnosis and clinical decision support information system and applications development under the notified measure “Intelligence . Joint business-science projects”;
Reinforcement of competitiveness under the notified measure “New Opportunities LT”.

DATA PROTECTION & PRIVACY

Softneta has appointed a Data Protection Officer, Raimundas Mikalauskas, in the implementation of the requirements of the General Data Protection Regulation (GDPR). Contact details – phone: +370 630 06808; e-mail: dpo@softneta.com.

Data subjects can see their rights here: Data Protection Rules: Rights of the Data Subject.

Request to exercise the data subject rights form can be found here: Request to exercise the data subject rights form.

Resellers of Softneta products can read the special conditions regarding the implementation of the General Data Protection Regulation and the Medical Device Regulation here: Special terms and Conditions regarding to GDPR and MDR.

Find out more about Softneta Privacy Policy.

Vulnerability disclosure policy

As a provider of medical software, SOFTNETA take security issues very seriously and recognize the importance of privacy, security, and community outreach. As such, we are committed to addressing and reporting security issues through a coordinated and constructive approach designed to drive the greatest protection for medical software users. If you believe you have discovered a vulnerability in our medical software or have a security incident to report, please contact SOFTNETA Data Protection Officer.

SOFTNETA will endeavour to keep the reporter apprised of every step in this process as it occurs.

We greatly appreciate the efforts of security researchers and discoverers who share information on security issues with us, giving us a chance to improve our software and better protect personal health data. Thank you for working with us through the above process.

We’ll do our best to acknowledge your emailed report, assign resources to investigate the issue, and fix problems as quickly as possible.

Our vision is to be a trusted technology partner and provide universal access to medical imaging and intelligence.

About us

EXECUTIVE TEAM & BOARD MEMBERS

INVESTORS

QUALITY POLICY

CERTIFICATIONS & REGISTRATIONS

EU PROJECTS & FUNDING

DATA PROTECTION & PRIVACY

Vulnerability disclosure policy