Quality Policy

S-Cube Technologies provides technology and regulatory solutions for the medical-device sector. We are committed to delivering reliable, compliant and customer-focused products and services that support customers in bringing safe and effective medical-device solutions to market.

To fulfil this commitment, S-Cube Technologies will:

• Maintain a Quality Management System that is appropriate to our purpose and context and supports our strategic direction.
• Understand and meet applicable customer, statutory, regulatory, contractual and other requirements relevant to our products, services and Quality Management System.
• Establish and review measurable quality objectives at relevant functions and levels, supported by clear responsibilities and appropriate resources.
• Strengthen customer satisfaction by delivering dependable solutions, responsive support and an effective customer experience.
• Select, monitor and collaborate with suppliers and external providers using criteria proportionate to their effect on the quality of our products and services.
• Promote competence, accountability, risk-based thinking and employee involvement so that everyone understands how their work contributes to quality.
• Consider whether climate change is a relevant issue when evaluating the context, risks and opportunities affecting the Quality Management System.
• Carefully select suppliers for software design and development, following strict criteria to provide the best quality of products and services.
• Commit to increasing the quality of products by carrying out plans to reduce the number of product defects and complaints, exceeding customers’ expectations.
• Continually improve the suitability, adequacy and effectiveness of the Quality Management System and the performance of our products, services and processes.

Framework for objectives

This policy provides the framework for establishing and reviewing quality objectives, with supporting arrangements defined in the Quality Manual and relevant QMS processes.

Communication and availability

The CEO shall ensure that this policy is maintained as documented information; communicated, understood and applied throughout the organisation; and made available to relevant interested parties, as appropriate.

Our broader quality commitment

The basic orientation of S-Cube Technologies is to be recognized as a leading company in the world as a provider of one-stop regulatory solutions that help life-saving medical devices get to market faster. This is achieved through: consideration of the context of the organization and aligning the Quality Management System with S-Cube Technologies’ strategic direction; assessing potential impacts of climate change on our operations, processes and procedures to contribute to global sustainability efforts; satisfying customer and applicable statutory and regulatory requirements for the seamless provisioning of the design and development of medical devices; strong management of the organization, along with employee-established quality objectives and defined responsibilities for their fulfilment; establishing, applying and maintaining a Quality Management System based on ISO 9001:2015 requirements; continual enhancement of customer satisfaction; improving users’ experience with customer support and sales teams specialized in the medical device domain; careful selection of suppliers for software design and development following strict criteria; a commitment to reduce product defects and complaints; making continuous improvement part of every day and every job; understanding how each role fits into the overall flow of work at S-Cube Technologies; and continuously upgrading the Quality Management System across every stage, from technology solution feasibility study, design, development, verification and validation, to production launch and software product maintenance in the market.

The framework for setting quality objectives is defined in the Quality Manual. The CEO is responsible for communicating the Quality Policy to all persons working for or on behalf of the organization, and for making it available to the public.