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TTP extends ISO 13485 certification to contract manufacture of medical devices and IVDs

TTP plc has expanded its ISO 13485 certification to include contract manufacturing of medical devices and IVDs, strengthening its end-to-end capability from development to include low- and mid-volume production.

News

TTP extends ISO 13485 certification to contract manufacture of medical devices and IVDs

Cambridge, UK, October 16th, 2025 - TTP plc, a leading independent technology and product development consultancy, has successfully extended its ISO 13485 certification to include the contract manufacture of medical devices and in vitro diagnostics (IVDs), including implantable devices and active implants.  

ISO 13485 is the internationally recognised standard for quality management in medical device design, development, production, and servicing.  

This scope extension builds on TTP’s 15-year track record of ISO 13485 certification for medical device development and further strengthens our ability to support clients, such as Glucotrack, in delivering innovative implantable solutions.

By integrating manufacturing with its core development teams, TTP enables clients to seamlessly transition from technology demonstrator to clinical trial manufacturing or early production for launch. The in-house manufacturing capability ensures projects stay on schedule and aligned with technology goals, followed by a smooth transfer to high-volume contract manufacturing when required.

This expanded certification means TTP now offers end-to-end support, from product development and manufacturing process design to low- and mid-volume production – all under ISO 13485 controls. You can view TTP's ISO 13485 certificate here.


About TTP's Manufacturing Capability

Working seamlessly with TTP development teams, TTP’s Manufacturing group can take your products through prototype builds, clinical trials, pilot manufacture and into ongoing production. With our dedicated manufacturing team and facilities including microfabrication, cleanrooms, electronics and mechanical assembly, TTP Manufacturing carries out controlled, traceable builds, reducing your development uncertainty, risk and time to market. Find out more about our manufacturing capability.

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