NETPark tenants CPI successfully renews its ISO certification for medical device quality management
CPI, an independent technology innovation centre and founding member of the UK Government’s High Value Manufacturing Catapult, has today announced the successful re-audit and renewal of its ISO 13485:2016 certification – the international standard for medical device Quality Management Systems (QMS). Compliance with ISO 13485 is a key part of meeting global regulatory requirements and allows CPI to continue offering an accelerated route to market for developers of medical devices.
ISO 13485 specifies a QMS that can demonstrate the ability to produce medical devices that consistently meet safety, customer, and regulatory requirements. The certification verifies that the design and development of physiological monitoring/diagnostic devices, accessories and services related to medical and IVD devices are safe for their intended purpose when using CPI’s National Healthcare Photonics Centre QMS. Compliance with ISO 13485 is often seen as the first step to receiving regulatory approval for new products.
To renew CPI’s ISO 13485 certification, Lloyd’s Register conducted a Surveillance 1 audit. Based on the assessment, the team recommended CPI’s recertification for the agreed scope, with all audit objectives achieved.
The accreditation allows CPI to continue advancing and enhancing its offering to the growing MedTech market. Customers developing innovative new devices containing photonics or electronics technologies will continue benefiting from working within a certified QMS. Working within this system throughout all stages of development ensures the production of high quality, compliant devices, while reducing the challenges associated with commercialisation. Smooth interactions with regulatory bodies also signal to investors that development is proceeding at the highest quality standard, lighting the path from innovation to commercialisation for CPI’s customers.
John Cocker, Director of Electronics at CPI, said: “At CPI, we continue to improve our systems and processes and welcome the contribution that external audits make. We are delighted once again to have been awarded this important certification, allowing CPI to continue supporting our partners in their development of medical devices and accelerating their entry to the market.”
News source: CPI
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The proximity to the universities and the infrastructure are very important factors. Ultimately having a presence in Europe is very valuable to us and we intend to stay at NETPark for many years to come.
The quality of the facilities at NETPark and the attitude of staff is first class. It has a really dynamic, innovative atmosphere.
CPI has developed a specialist offering to support SMEs looking to develop their printable electronics applications and our partnership with Business Durham has been instrumental in attracting several SMEs to locate here in the region.
It fits perfectly for us that we’re surrounded by like-minded companies at NETPark. There are a number of highly skilled people in the area who can help us grow our business. The facilities and services offered by NETPark are first class, they make office life simple and engaging.
Access to quality facilities was one of the main drivers for deciding to locate the business at the NETPark. We have been able to use this as a launch pad to link into support from CPI and world-class expertise from Durham University.
We initially came because of the printable electronics centre but access to a highly skilled semi conductor workforce in the North East has been a key factor in us staying and growing here, as well as the value for money office space and the access to funding.