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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. In a recent project incorporating International Medical Lasers, the certification verifies that the design and development of physiological monitoring and 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.

CPI’s renewed ISO 13485:2016 certification underscores its unwavering commitment to providing high-quality support for the development of medical products. As a key player in the UK Government’s High Value Manufacturing Catapult, CPI continues to advance innovation across multiple sectors, including healthcare. This certification assures that the technologies and solutions they offer, such as those used in medical device design and development, adhere to the highest standards of safety and efficacy.

One area where this commitment to quality is particularly significant is in the development of medical alert devices for individuals seeking to maintain their independence. These devices play a crucial role in ensuring the safety and well-being of users, especially for the elderly or those with chronic health conditions. With the growing demand for solutions that promote an independent lifestyle, the medical alert system benefits are increasingly recognized. These systems offer peace of mind, allowing users to quickly alert emergency services in the event of a fall or medical emergency.

Furthermore, the integration of such devices with advanced monitoring technologies ensures that medical professionals are alerted in real-time, improving response times and potentially saving lives. As CPI continues to push the boundaries of healthcare innovation, their support for the development of medical alert systems stands as a testament to their commitment to improving lives through cutting-edge medical technology.

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.”

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