Camgenium achieves exceptional ISO 13485 audit result from BSI for compliance to medical device standards

Camgenium, a leading medical device software engineering company, announces its recertification to the ISO 13485 standard by long-established UKAS certified auditor BSI.  Once again, BSI found no non-compliances, gave no recommendations for improvement and, moreover, commended Camgenium on its electronic Quality Management System (eQMS) and understanding of the standard. 

Camgenium’s CEO, Dr Philip Gaffney OBE, commented, “This result evidence Camgenium’s commitment to excellence in its work developing and deploying medical device grade software solutions for its customers.” Camgenium, previously known as L2S2, has been continuously certified to ISO 13485 since 2016. 

ISO 13485 ensures medical devices are safe for their intended use and demonstrates the manufacturer’s commitment to quality and safety. The standard applies to organisations involved in the design, production, deployment, installation and servicing of medical devices and related services. When developing a new medical device product, it is vital to work with a software partner who is proven to work to ISO 13485 to ensure regulatory approval.

Camgenium’s COO, James Belcher explains “We are delighted to once again achieve this recognition from the ISO 13485 auditor. The team at Camgenium works hard to maintain the exceptional levels required to meet these standards and it is truly fulfilling to have our dedication rewarded.”

James Belcher continues, “Our mission is to increase the speed at which we bring our customers’ new medical devices to market, whilst reducing risks and costs of development and deployment. Compliance to ISO 13485 is the bedrock of our medical device work at Camgenium.”

Camgenium’s electronic Quality Management System (eQMS) has been developed and built in-house using its proprietary Xenplate software platform. The Xenplate system is fully auditable and so is aligned with the requirements of ISO 13485. The eQMS is also used to manage Camgenium’s compliance and certification to ISO 27001, the information security standard.