Sagentia Innovation’s Cambridge-based R&D center has been awarded ISO 13485 accreditation for manufacturing medical devices, enabling it to offer an adaptive and flexible production service for clients that need to get to market fast.
In 2008 Sagentia Innovation acquired ISO 13485 accreditation to design and develop medical devices to client specifications. This new, extended accreditation enables the business to offer in-house, small-scale manufacturing, which can significantly speed up product launches and provide cost efficiencies for their clients. In addition, the new service offer could benefit clients across all four market verticals that Sagentia Innovation serves: Consumer; Food & Beverage; Industrial, Chemicals & Energy; and Medical.
As a selected participant of the UK Government’s Ventilator Challenge, Sagentia Innovation had to ensure that it quickly manufactured tens of thousands of units on-site, meeting medical device quality standards. The compliance of its processes, procedures, templates, and quality plans has now been formalized to underpin future manufacturing needs.
The science, product, and technology development company embarked on the accreditation journey following its involvement with the UK Ventilator Challenge. As well as having space, resources, and capability to offer to manufacture, it could see a significant benefit this would bring to clients, enabling better control of transfer to manufacturing and therefore shortening the time it takes to get a product to market.
Rob Morgan, Managing Partner, Medical, says extending the accreditation to encompass manufacture means Sagentia Innovation can help clients adapt to evolving healthcare demands quickly:
“Offering R&D strategy, design, development, and manufacture all from one facility enable us to streamline and accelerate the innovation process,” Morgan explains. “There are many scenarios that demand rapid turnaround of entire products or vital components, from the manufacture of new devices for clinical trials to the short-run production of niche components to enhance existing products. From diagnostic to surgical applications, the same robust quality standards need to be adhered to.”
The flexibility of Sagentia Innovation’s manufacturing capability offers further advantages for clients seeking a short production run ahead of a wider rollout. Morgan says care is then taken to align processes with those of the clients’ own manufacturing facilities or largescale contract manufacturers to ensure a frictionless transfer.
“Our engineers consider long-term requirements from the outset then take steps to maximize simplicity and avoid potential complications at every stage of the process. This new accreditation strengthens our ability to help clients realize their product ambitions quickly and compliantly.”