Inspiration Healthcare Group, a global supplier of medical technology for critical care, operating theatre and home healthcare applications, is adopting software from Ideagen to enhance regulatory compliance and key operational processes.
Ideagen Q-Pulse, Ideagen’s flagship quality management software, will help the company maintain high levels of compliance to a number of regulatory bodies such as ISO 13485:2016, FDA 21 CFR part 820 and European Medical Device standards.
Inspiration Healthcare manufactures and distributes its products to over 50 countries globally and will also adopt Q-Pulse for operational process management, particularly in relation to Design File History management – a key requirement for medical device manufacturers.
Simon Travers, Head of Quality Assurance and Regulatory Affairs at Inspiration Healthcare, said: “For both compliance and operational reasons it was imperative that we brought Q-Pulse in. The software will make it easier for us to comply with several standards and satisfy the strict requirements of those notified bodies.
“Although regulatory compliance was the main reason for adopting the software, there were many process reasons also. There will be document control and review, audit, corrective and preventive action benefits – not to mention Q-Pulse becoming a central repository for the management and review of suppliers, assets and staff competency management.”
Inspiration Healthcare provides high-quality innovative products to patients and caregivers around the world that help to improve patient outcomes and efficiencies of healthcare organisations. Its products cover non-invasive respiratory management, thermoregulation, and patient warming for newborn babies through to adults in intensive care and the operating theatre.
The company’s distribution business supplies solutions to support specialised surgical procedures and infusions therapies.
A particular area of focus for the new Q-Pulse system will be in the management of the company’s Design File History documentation. Simon explained: “Within the medical device industry, organisations such as ours are required to maintain a Design History File – basically a complete story of how a product is created – for every product that is designed and taken to market.
“We will be using the standard change request functionality within Q-Pulse to conduct periodic reviews every 12 months of our DFH documentation, ensuring we are on top of them. Q-Pulse will automatically remind stakeholders that a review is upcoming or overdue.”
Ideagen, a UK-based software company which has a global footprint, provides software and services to more than 400 healthcare organisations globally, including 75% of the UK NHS. Other clients in this sector include Nuffield Health, Great Ormond Street Hospital, Spire Healthcare and El Camino Hospital.
Ideagen’s software solutions – such as Ideagen Q-Pulse – help organisations manage quality, safety and compliance while improving patient care outcomes and clinical and operational efficiency.