Quality Policy
ICONIC SOLUTIONS BY MURCIA, SL (INBENTUS), in the field of design of automatic mechanical ventilation systems, aims to be a leader in its field. To this end, we are committed to designing, manufacturing and supplying medical devices that improve the health and well-being of patients around the world. Our dedication to excellence is driven by a commitment to quality, safety and efficiency in all aspects of our operations, from initial design through post-market surveillance.
Commitment to rules and regulations:
We meet the highest industry standards and regulatory requirements to ensure the safety and reliability of our medical devices. This commitment is underscored by our strict compliance with, among others:
- ISO 13485:2016 for quality management systems, ensuring consistent design, development, production, installation and delivery of medical devices that meet regulatory and customer requirements.
- EU Medical Device Regulation (MDR) 2017/745, which guides our operations within the European Union, emphasizing the safety and performance of our devices throughout their lifecycle.
- ISO 14971 for the Application of Risk Management to Medical Devices, ensuring that risks associated with our medical devices are effectively identified, assessed and controlled.
- Other applicable regulations, including, but not limited to, FDA regulations for the U.S. market, which ensure a comprehensive approach to quality and safety.
Risk management:
Risk management is at the core of our Quality Management System. We proactively identify, assess and mitigate risks throughout the product life cycle, ensuring that our medical devices are safe for their intended use. Our comprehensive approach to risk management is aligned with the principles of ISO 14971, integrating risk analysis into product design, development and post-marketing activities.
Post-marketing activities:
We are committed to monitoring the performance and safety of our medical devices after they have been placed on the market. This commitment involves:
- Post-marketing surveillance for early detection of any potential problems.
- Prompt and effective corrective action, including product recall, if necessary, to ensure continued patient safety.
- Periodic reporting to regulatory authorities in accordance with MDR 2017/745, FDA regulations and other local requirements.
Continuous improvement:
Continuous improvement is a cornerstone of our quality policy. We are dedicated to continuous improvement of our quality management system, products and processes through periodic reviews, employee training, customer feedback and performance metrics. Our goal is to exceed customer expectations and regulatory standards, fostering innovation and excellence in medical device manufacturing.
Employee involvement:
Our employees are our most valuable asset in achieving our quality objectives. We foster a culture of quality, integrity and accountability, where every team member is trained and expected to contribute to our quality objectives. Through continuous training and professional development, we ensure that our team remains at the forefront of industry standards and best practices.
Management commitment:
The INBENTUS management team is fully committed to maintaining this Quality Policy, to providing the necessary resources for its implementation and to ensuring that it is communicated, understood, implemented and maintained at all levels of the organization. In addition to the above, INBENTUS is committed to:
- Work with suppliers and subcontractors committed to the constant improvement of their product or service, ensuring both quality and competitive pricing.
- To have qualified employees who, together with the appropriate technological resources, guarantee the constant quality of our services.
- Involve all members of the organization in the development and continuous improvement of the implemented system.
- To have the necessary tools to evaluate and know the expectations of our customers and stakeholders, adopting the appropriate measures to achieve their full satisfaction with our work.
- Consider the evolution of the context applicable to the organization as input for the improvement of the system.
- Ensure the protection of confidential information and the rights of customers.
Management shall provide the necessary means to ensure that this Quality Policy is understood, implemented and kept up to date throughout the organization and its stakeholders.
Review and modification:
This Quality Policy will be reviewed annually and revised as necessary to reflect changes in regulatory requirements, customer expectations and our strategic objectives.
