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Security Excellence!

bioMDx Intelligence is established by experienced Healthcare and Intelligence professionals, with a vision to providing solutions, products and services, that improve people’s lives, contributing to healthier and safer communities. 

Aiming to “Safety and Security”, we offer the latest Scientific and Technological advancements not only for the Safety in HealthCare, but also for the Citizen´s Security.

We are already assigned as official Authorized Distributors and Resellers in Greece and in Cyprus of leading companies, such as Cerus (www.cerus.com, www.intercept.com) in the area of blood transfusion safety, Secom Italia (www.secomitalia.com) in the field of electronic suspect identification systems, Cellebrite (www.cellebrite.com) and Bold (www.boldintel.com)in the field of digital forensics and information analysis.

The Company’s Quality Management System has been developed based on the International Standards ISO 9001:2015 (Quality Management Systems-Requirements), ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes), ISO 14001:2015 (Environmental management systems), ISO 37001:2016 (Anti-bribery management systems) ISO/IEC 27001:2022, and the Ministerial Decision 1348:2004, which contains basic requirements regarding the development and implementation of Quality Management Systems.

The main objective of the Company’s Unified Management System is to create a basis for the continuous improvement of the efficiency of its processes, always with a view to the continuous satisfaction of the needs and expectations of its customers to the maximum extent possible.

In order to achieve the above, the Management supports and continuously applies the basic principles and rules that govern the Company’s Unified Management System, establishing objective objectives for quality, based on the undivided and constructive cooperation of both its employees and its partners.

The basic principles as expressed within the procedures of the Company’s Systems Management Manual are:

  • Compliance with the legislative and regulatory framework governing the operation of the Company. Particular attention is paid to the management of personal data of patients which the Company maintains. Adherence to prescribed customer requirements as agreed through written contracts/agreements in order to increase customer satisfaction
  • Compliance with the requirements of both the Ministerial Decision ΔΥ8/1348/2004 regarding the “Determination of the Quality System of Medical Device Companies” and the requirements of the standards EN ISO 9001:2015, EN ISO 13485:2016, EN ISO 14001:2015, EN ISO 37001:2016 as well as the EU directives-regulations governing medical devices.
  • Continuous after-sales customer support and constructive cooperation with all suppliers.
  • Continuous information and training of the staff.
  • The investigation of causes of non – conformities or complaints and further determination of corrective actions.
  • Operating with environmentally friendly practices and based on legal and regulatory requirements related to climate change.

The principles of the system as well as the objectives for quality are regularly reviewed by the Company’s Management in order to adapt to new needs and developments in the commercial world, legislative requirements and to achieve the objective of continuous improvement of the Company’s operations.

Through the continuous reviews of the above, the Management is in constant search to identify both human and logistical needs. Management is committed to providing the resources required to meet the needs as they arise and are shaped by the existing situations to the best of its ability.

All departments of the Company have the responsibility to meet, assimilate and implement the procedures required by the Quality System through their daily activities.

It is also the responsibility of the Company’s Management to ensure that the Quality Policy is communicated, understood and applied by all the Company’s human resources, with the ultimate goal of continuous, steady growth of the Company’s business with unwavering commitment to its principles and the continuous offer to its customers of products and services of excellent quality.

The Management of BIOMEDIX is aware of the environmental impact of its business activities.

For this reason, BIOMEDIX records, analyzes and implements environmental programs aimed at reducing its impact on the environment and is constantly working to expand and continuously improve its environmental footprint. This environmental policy is an integral part of the Company’s corporate and product strategy.

BIOMEDIX Management is committed to continuously improving the Company’s environmental footprint through:

  • The identification of the Company’s environmental aspects & impacts per process/activity and the assessment of their criticality,
  • The recording and analysis of environmental data related to the Company’s performance, in particular:
  • The consumption of natural resources,
  • The recycling of materials (e.g. electrical/electronic equipment, batteries).
  • The production of solid and liquid waste,
  • The production of hazardous waste (e.g. batteries, non-recyclable products),
  • CO2 emissions into the atmosphere from transport implementation.
  • The implementation of environmental programmes to reduce impacts assessed as critical,
  • The setting of measurable targets & corresponding indicators (KPIs) for the environment,
  • The identification and assessment of potential risks and opportunities related to the environment, by process/activity, and the adoption of measures to prevent and address them,
  • The maintaining of the high level of environmental awareness of the executives through continuous training and information,
  • The periodic evaluation of all suppliers, partners and subcontractors of the Company according to quality and environmental criteria,
  • The implementation of contingency plans to ensure the protection of personnel and third parties as well as the protection of the environment,
  • The implementation of a Management System in accordance with the International Standard ISO 14001:2015.

For this purpose, BIOMEDIX continuously and systematically checks the applicable legal guidelines and requirements arising from these relevant operations, which are then documented and integrated into the Company’s Management System.

The Company’s Unified Management System is audited by an independent certification body, ensuring that BIOMEDIX’s commitment to environmental management can be compared to domestic and international benchmarks.

It is also the responsibility of the Company’s Management to ensure that the Quality Policy is communicated, understood and implemented by all the Company’s human resources, with the ultimate goal of continuous, steady growth of its business activity with unwavering commitment to its principles and the constant offer to its customers of products and services of excellent quality.

The Company declares zero tolerance to all forms of Active and Passive Bribery and “Prohibits bribery in any form and the payment of money or any other kind of payment, indirect or direct (provision of business opportunities, jobs, favourable contracts, donations, travel, gifts and hospitality) in order to obtain or maintain or secure an (improper) advantage for the Company.”

In this context, it has incorporated into its Quality System the requirements of the ISO 37001:2016 “Anti-Bribery Management System” standard and is committed to its compliance.

The anti-bribery prevention measures are expressed within the procedures of the Company’s Quality System and are:

  • Recognising the risks of bribery.
  • Compliance with the relevant Legislative and Regulatory framework related to Bribery.
  • Implementation of policies and rules to ensure Ethical Transactions.
  • Regular review of Policy suitability for the Company’s Purpose.
  • Definition of anti-bribery objectives.
  • Conducting due diligence checks on involved personnel and business partners.
  • Conducting ongoing training for staff to prevent Bribery and encourage reporting of incidents.
  • Provide protection for the complainant.
  • Ensure the independence and impartiality of the Anti-Bribery Facility.
  • Provide a mechanism for anonymous complaints.
  • Impartially investigate incidents of Bribery and impose consequences on those involved.

The principles of the system as well as the objectives for quality are regularly reviewed by the Management Board in order to be continuously improved.

The Management is committed to providing the necessary resources to maintain and implement the Anti-Bribery System.

All departments of the Company have a responsibility to meet, assimilate and implement the procedures required by the Anti-Bribery System through their daily activities.

It is also the responsibility of the Company’s management to ensure that the Anti-Bribery Policy is communicated, understood and implemented by all Company personnel.

The main objective of BIOMEDIX’s Unified Management System is to create a basis for information security, always having in mind the continuous satisfaction of the needs and expectations of its customers to the maximum extent possible.

In order to achieve the above, the Management supports and continuously applies the basic principles and rules that govern the Company’s Unified Management System, establishing objective goals for information security, based on the undivided and constructive cooperation of both its employees and its partners.

The basic principles as expressed within the procedures of the Company’s Unified Management System are:

  • The compliance with the legal and regulatory provisions related to the activity of the Company.
  • The recognition of the requirements and the consequent needs of the customers
  • Compliance with the requirements of the ISO/IEC27001:2022 standard.
  • Continuous customer support after the sale as well as constructive cooperation with all partners
  • Continuous information and training of the staff
  • Investigating the causes of non-compliances or complaints and further determining corrective actions
  • Protecting the interests of the company and those who deal with it and trust it for the use and handling of their confidential data
  • Ensuring the availability, integrity and confidentiality of information generated, received and handled in the context of security projects.
  • To maximise the reliability of its information resources.
  • Improving energy efficiency.
  • Promoting the use of renewable energy sources.
  • Implement sustainable waste and natural resource management practices to reduce the impact of the Company’s operations on the environment and climate change.
  • Working with suppliers and other stakeholders to promote sustainable practices.

The principles of the Unified Management System as well as the objectives for information security are regularly reviewed by the Company’s Management in order to adapt to the new needs of direct and indirect customers, legislative requirements and to achieve the objective of continuous improvement of the Company’s operations.

Through the continuous reviews of the above, the Management is in constant search for the identification of both human and logistical needs.

The Management is committed to:

  • Providing the necessary resources to meet the needs, as they arise and are shaped by existing situations, to the maximum of its ability.
  • To comply with the legislative and regulatory framework governing the operation of BIOMEDIX.
  • To adopt energy efficient technologies and practices to reduce energy consumption in the offices and use renewable energy sources wherever possible.
  • To implement recycling and waste reduction programs
  • To continuously seek necessary resources to serve its commitment to continuous improvement, taking into account the impact of climate change
  • To incorporate sustainable practices into the Company’s operations.

In this direction, the Unified Management System Manager was appointed by the Management as its representative in matters of Information Security.

All BIOMEDIX departments have the responsibility to meet, assimilate and implement the processes required by the Unified Management System through their daily activities.
It is also the responsibility of BIOMEDIX Management to ensure that the Information Security Policy is communicated, understood and implemented by all the Company’s human resources, with the ultimate goal of continuous, steady growth of its business activity with unwavering commitment to its principles and the constant offer to its customers of services of excellent quality.

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