CPI, an independent technology innovation centre, has announced the organisation has been awarded the international standard for medical device quality management systems.
ISO 13485 specifies a quality management system that can demonstrate the ability to produce medical devices that consistently meet safety, customer, and regulatory requirements.
Complying with this standard is a pivotal part of meeting global regulatory requirements. CPI’s certification will enable the organisation to offer an accelerated route to market for medical device developers.
A comprehensive quality management system is needed to receive this certification which is a requirement for the CE marking of all but the lowest risk medical devices. Therefore, complying with ISO 13485 is often seen as the first step to receiving regulatory approval for new products.
John Cocker, director of electronics at CPI, said: “We are proud to be awarded this important certification. Working with a compliant partner like CPI enables companies to develop safe and effective medical devices, while also reducing the time and costs required to take a product to market.
“Our customers will also benefit from the strong reputation of ISO 13485, as it demonstrates to investors and the market that a professional approach was adopted from the outset.”
CPI believes this accreditation significantly enhances the centre’s offering to the medtech market.