Quality & Compliance
Quality and Environmental Responsibility Throughout the Product Lifecycle
At IVUS Medical, quality and environmental responsibility are integral parts of how we develop and manufacture our products.
Our management systems provide the framework for ensuring consistent product quality, regulatory compliance and continuous improvement, from product development and supplier selection to manufacturing, documentation and post-market activities.
IVUS Medical is certified according to ISO 9001, ISO 13485 and ISO 14001, reflecting our commitment to quality, patient safety and responsible environmental management.
Our Approach
Quality, compliance and environmental responsibility are integrated into the way we develop and manufacture our products. Our approach is built around four key principles:
Product Quality
We focus on consistent product quality throughout the entire product lifecycle, from development and material selection to manufacturing and final product.
Regulatory Compliance
Our products and processes are managed in accordance with applicable regulatory, statutory and customer requirements.
Traceability
Documented processes and traceability throughout the product lifecycle help us maintain control and ensure consistent quality.
Continuous Improvement
We continuously monitor and improve our products, processes and management systems to maintain high standards of quality and environmental performance.
Quality Policy
Quality is fundamental to the development and manufacture of IVUS products.
IVUS Medical operates a quality management system certified according to ISO 9001 and ISO 13485. Our quality management system supports consistent product quality, regulatory compliance and continuous improvement throughout our organisation.
We are committed to:
- Developing and manufacturing safe, reliable and high-quality products
- Understanding the needs of healthcare professionals and users
- Meeting applicable regulatory, statutory and customer requirements
- Maintaining effective control of suppliers and manufacturing processes
- Ensuring appropriate documentation and traceability throughout the product lifecycle
- Monitoring product and process performance
- Continuously improving our products, processes and quality management system
Our quality objectives are established, monitored and reviewed regularly to ensure that our quality policy is translated into measurable actions and continuous improvement.
IVUS Medical complies with the applicable requirements of Regulation (EU) 2017/746 (IVDR) for our IVD products and other applicable regulatory requirements.
ISO 9001 & ISO 13485
Environmental Policy
Environmental responsibility is an important part of how we operate and develop our business.
IVUS Medical operates an environmental management system certified according to ISO 14001. Through our environmental management system, we work systematically to identify, assess and reduce the environmental and climate impacts associated with our activities and products.
We are committed to:
- Considering environmental impacts throughout the product lifecycle
- Assessing environmental and climate-related risks and opportunities
- Working with suppliers and manufacturing partners to support responsible production
- Considering resource consumption, packaging, transportation and waste
- Complying with applicable environmental legislation and requirements
- Setting and reviewing environmental objectives
- Continuously improving our environmental performance
Where relevant and practicable, we consider environmental aspects from product development and material selection through manufacturing and transportation to use and end-of-life.
Our environmental efforts support the principles of United Nations Sustainable Development Goal 12 – Responsible Consumption and Production.
ISO 14001