ISO 13485 accreditation for manufacture of medical devices | Sagentia Innovation

Market insights to rapid manufacturing; Sagentia Innovation gains accreditation for medical device manufacture

This new, extended accreditation enables Sagentia Innovation to offer in-house, small-scale manufacture, which can significantly speed up product launches and provide cost efficiencies for our clients.

In 2008 Sagentia Innovation acquired ISO 13485 accreditation for the design and development of medical devices to client specifications. This new, extended accreditation enables the business to offer in-house, small-scale manufacture, which can significantly speed up product launches and provide cost efficiencies for their clients. 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 was able to quickly manufacture 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 formalised 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 the space, resource and capability to offer manufacturing, it could see the significant benefit this would bring to clients, enabling better control of transfer to manufacture 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 enables 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. In every situation, 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 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 maximise simplicity and avoid potential complications at every stage of the process. This new accreditation strengthens our ability to help clients realise their product ambitions quickly and compliantly.”

For further information visit us at: www.sagentiainnovation.com or email info@sagentiainnovation.com

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