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Product Safety

Our products directly impact the quality of life – so our standards are high and we aim to improve at every opportunity. 

We employ rigorous product design, development, testing and manufacturing processes to ensure that our products are of the highest quality, are safe and reliable to use and meet medical device regulatory requirements.

Quality Management System

Quality Management System

Quality and safety of our products is our top priority - and we manage this through our Quality Management System (QMS). Our QMS ensures that our products are designed, developed, and manufactured to meet customer and regulatory requirements, and to reinforce customer satisfaction through product and service performance. Extensively tested before being released for production, only products that meet our safety requirements are released for distribution.

ISO Certification

ISO Certification

To ensure that our QMS remains robust and is continually improving, the majority of our facilities have either ISO 13485 or ISO 9001 certification. These certifications demonstrate that we are committed to total quality management, to ongoing customer focus, and to a continually improving process approach throughout the organization. This also means that critical processes and their interactions are understood and documented, and that there is a strong management commitment to the elements of the ISO quality management standard.

Regulatory Compliance

Regulatory Compliance

Our products are classified as medical devices. As a result, they are subject to various medical device regulations throughout the world, such as the Medical Device Regulation (MDR) in the European Community and the Food and Drug Administration (FDA) in the United States. The exacting standards we apply throughout the design, development, testing, and manufacturing processes are there to ensure that we comply with all such regulations. We employ a specialized team of Regulatory Affairs Associates who work toward implementation of new rules within internal practices and processes.

As both an associate with Sunrise and a user of Sunrise Medical products, I find my dual perspective incredibly beneficial in developing product specifications and testing new products. Viewing our products through the lens of a user is invaluable, providing insights that are crucial for successful product development. One of the greatest challenges is leveraging my expertise in Product Management alongside my personal user experience to ensure we create products that truly enhance people's lives.

Michael Kroener

VP Product Management (Europe)

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