Kanteron Systems is Healthcare Products Producer’s License number 5812-PS issued by the Spanish Ministry of Health and Social Policy – Directorate of the Spanish Healthcare Product Agency.
Kanteron Systems’ solutions have the European Quality Mark CE/1 as required by Article 12 of the Medical Devices Directive 93/42/EEC and conformity assessment for medical devices in section 2.5 of Guidance MEDDEVs, have certified our quality system EN ISO 9001:2008 by Bureau Veritas (BVQi) number 8001731 ENAC, and are listed as software vendors by the Digital Pathology Association (USA).
On October 5, 2016, FDA’s Team Leader,
CDRH Registration and Listing Program, officially communicated to Kanteron Systems that the Agency (FDA) does require compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health. Therefore, Kanteron Systems does not require registration and listing at this time anymore. For the record, it was classified and registered for the past few years in the FDA Unified Registration and Listing System (FURLS) Device Registration and Listing Module (DRLM) LMD Registration Number: 3010408861
Owner/Operator Number: 10044162
Listing: D194733 as:
LMB 21 CFR 892.2010 DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
LMD 21 CFR 892.2020 SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL
OUG 21 CFR 880.6310 MEDICAL DEVICE DATA SYSTEM
So, the current FDA regulatory status of Kanteron’s platform according to the 21st Century Cures Act (Cures Act – Public Law No. 114-255) Section 3060/C/D/E is: excluded from the definition of a “device” software.
Kanteron Systems complies with the Electronic Industry Citizenship Coalition Code of Conduct (“EICC Code of Conduct”) and our products and services are covered by Product Liability Insurance provided by Chubb Insurance Company. Kanteron Systems has earned the Cyber Essentials badge from the UK Government for following computer security best practices.
To ensure the compliance of all our actions with our Quality Policy and our Environmental Management, Kanteron Systems Management team has established and implemented a Quality and Environmental Management System, based on UNE-EN ISO 9001:2008 standard requirements. “Environmental Management Systems . Requirements with guidance for it’s use”.
Our Quality and Environmental Management is based in the following commitments:
- Commitment to meet all the requirements, whether legal, contractual or otherwise that are applicable based on our activity, both in terms of the performance of our processes and the environmental scope of our activities, so our action in no case may contravene legal requirements and specifications set by the various public authorities.
- Commitment to carry out our work within a management environment that ensures continuous improvement in our processes, our methods of action and in our relationships with the stakeholders, by establishing and regularly reviewing our quality objectives and our environmental goals.
- Commitment to protect the environment through actions and measures geared to preventing any contamination that might result from operations due to our activity.
- Commitment to promote an understanding and broadcast of our quality policy and environmental management within our organization through training and continuous communication with our employees and all companies working for or on behalf of Kanteron Systems.
- Commitment to effectively control all our processes, with particular emphasis on : – The Quality of our products – Efficiency and effectiveness of our services – Relationships with customers – Waste control, especially those owned by our customers.
- Commitment to make available to the general public our quality policy and environmental management, on our website.
Purpose : To conserve natural resources and environmental protection.
As a software service provider, Kanteron Systems takes into account any impact our activities can cause on our environment. We are sensitive to environmental conservation and we try to reduce any harmful effects of our activities, protecting the safety and wellness of our staff.
Our environmental initiatives are focused on the following areas:
– Energy (office and equipment)
– Travel policies
– Waste management
We try to: Comply with local and international environmental legislation, raise environmental awareness of our employees, adopt best practices and check the progress at each point.
Quality disclosure: until today, Kanteron Systems has received NO fines or penalties due to quality, product, or environmental issues. However, if we receive any in the future we will include it in our website.
Energy use: We aim to consume less and to reduce our environmental impact, to reduce the greenhouse gas that produces the energy consumption.
Kanteron Systems has currently established the following goals:
- For energy conservation: to reduce energy consumption by 5% per employee per year since implementing the environmental program.
- To reduce Scope 2 greenhouse gas emissions: reduction of by 5% per employee per year since implementing the environmental program.
Travel policies: The objective is to reduce to the extent possible the use of resources that impact the environment, we try as much as possible to use and enhance:
- Tele -Work
- Flexible working hours (to avoid traffic jam hours) always according to our labor legislation.
Waste management: encourage individual responsibility of our employees and partners by promoting the following:
- Reducing the use of paper: our goal is to reduce paper consumption by 5 % annually, implementing duplexing and transmission and exclusively digital document processing.
- We provide various types of recycling containers (paper, plastic, and glass).We use recycled and recyclable materials s much as possible, and non-toxic, recycled and 100% recyclable waste.
- Special waste (such as computer equipment, electric batteries, or neon tubes) are disposed of in accordance with local law: using collection systems that public administration makes available to all local businesses in these cases.
In addition, we donate assets that are no longer useful for our activity, but can be used for other purposes, to people who otherwise would not have access to them (schools, almshouses, etc).
Kanteron manages a policy, guidelines, and procedures that govern our operation. The policy provides the framework for our organization development, which contains:
- Human Resources Policy
- Information Technology Policy.
- Purchasing policy, including ethical standards in our choice of supplier.
- Environmental policy.
All employees follow this policy as a condition of employment. Our policy is accessible to all employees.
The human rights principles considered by Kanteron respect internationally approved principles related to human rights, labor rights and anti-corruption.
- The protection of internationally proclaimed human rights.
- Freedom of association and the effective recognition of the right to collective bargaining.
- The elimination of all forms of forced and compulsory labor.
- The effective abolition of child labor.
- The elimination of discrimination in respect of employment and occupation.
- The abolition of corruption in all its forms, including extortion and bribery.
Wages and Benefits:
Kanteron remunerates its employees in accordance with the legislation in force in all our functional positions, this includes compliance in payments to our employees, legally established rights and all other regulated compensation elements, included in the Spanish labor legislation.
Work-life balance :
Kanteron considers employees are its main asset, we are a company that promotes a dynamic, balanced environment that creates opportunities for our team to work, live and enjoy. We focus on finding the right balance between professional work and private life; promoting health and well-being of our people; maintaining and improving staff morale and personal development to enable our team reach its full potential.
Kanteron has structured its work practices to ensure the normal course of business, demanding working hours the employee within the normal local work hours.
(In Spain, for this type of work are 40 hours per week and overtime with special remuneration).
Health and security:
All our employees are covered by compulsory insurance by law. Kanteron provides a comfortable environment for its employees and contractors. Considering the revision of essential safety work environment, review of the use of chemicals that do not use (that’s why it’s so easy that review -who writes these documents? 😉) and ergonomic furniture in the workplace.
Kanteron keep records to demonstrate and ensure the compliance of all these points. Our records are retained for at least the minimum legislated period.
All new staff is informed of Kanteron’s policies by signed electronic notification.