Cambridge, UK – TTP, the leading leading independent technology and product development company, this month announced that it has successfully extended its ISO 13485 certification to cover 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 the design, development, production, and servicing of medical devices.
This scope extension builds on TTP’s 15-year track record of ISO 13485 certification for medical device development and further strengthens the company’s ability to support cutting-edge work in implantable devices with clients such as Glucotrack, a company developing innovative continuous glucose monitoring (CGM) solutions for people with diabetes.
“At TTP, our manufacturing team’s mission is to ensure clients can move from prototype to production with confidence,” said Will Cramer, who heads up TTP’s manufacturing team. “Extending our ISO 13485 certification means clients can have the confidence that we follow compliant practices - from early-stage development through to clinical trial manufacturing and early production for launch.”
By keeping manufacturing in-house, TTP helps clients seamlessly transition from technology demonstrator to clinical trial manufacturing. When clients are ready to scale, TTP provides end-to-end support and ensures a smooth transfer to full-scale contract manufacturing with trusted third parties. This approach allows companies to make the move at the right time, avoiding disruption at critical points in their growth journey.
Whether a project requires hundreds or thousands of units before scaling to millions, TTP offers end-to-end support: from development and manufacturing process design to production - all under ISO 13485 quality controls.
See TTP's ISO 13485 certification here.
Learn more about TTP's manufacturing and medical device consulting here.
About TTP plc
TTP is a leading independent technology and product development company based in Cambridge, UK. With deep expertise across science, engineering, and product design, TTP works with global partners to create innovative solutions in medical devices, life sciences, and beyond.
