Aparito is pleased to announce we have achieved the ISO 13485:2016 accreditation from BSi under the certificate number: MD721810.
ISO 13485 is an internationally agreed standard that sets out the requirements for a Quality Management System (QMS) specific to the medical devices industry to meet the increasingly stringent regulatory requirements throughout a product’s life cycle.
This accreditation was awarded for our Quality Management System (QMS) for the design, development, manufacture and installation of our patient management software platform, Atom5™.
To achieve the accreditation Aparito had to demonstrate its ability to provide medical devices and related services that consistently met customer and applicable regulatory requirements.
The ISO 13485 standard is built on a set of quality management principles to create a culture of continual improvement, ensuring customer satisfaction and compliance. These principles are essential in ensuring that we are a trusted partner, providing safe and secure solutions for our patients and customers.
Aparito’s Founder; Dr Elin Haf Davies, who as an ex-regulator, purposely built the company with a culture focused on safety, quality and compliance; comments:
“This accreditation is a significant step in our journey to deliver a positive impact to patients living with life-limiting diseases through our SaaMD (Software as a Medical Device) remote patient management software platform Atom5™ – providing data collection and analytical solutions. I am immensely grateful to my team for their hard work and dedication to get our accreditation completed.”
Dr Elin Haf Davies – CEO Aparito