We’re proud to announce that, following a comprehensive one-day audit conducted by NQA, we have successfully retained accreditation for both ISO 9001 and ISO 13485 standards for another year.

This continued certification reflects our unwavering commitment to excellence across our research, product design and prototyping services. It reaffirms that quality and innovation can, and must – go hand in hand.

Building Confidence Through Compliance

For clients operating in highly regulated industries, particularly medical technology, accreditation provides peace of mind. It ensures that every stage of the development process meets the most rigorous international standards.

• ISO 9001 certifies that our Quality Management System (QMS) drives consistency, reliability, and continual improvement across all projects.
• ISO 13485, the dedicated medical device standard, demonstrates that ITERATE has the systems, documentation, and processes in place to design and develop devices that are safe, effective, and compliant with regulatory expectations.

These accreditations don’t just validate how we work, they enable our clients to innovate with confidence. Our customers know their product journey is fully supported by a trusted, quality-led partner.

Advancing Healthcare Through Design and Engineering

Over the years, ITERATE has partnered with a range of forward-thinking medical innovators to turn pioneering ideas into life-changing technologies. From early feasibility to launch-ready prototypes, our team blends design thinking with engineering rigour. This is to accelerate development and reduce risk.

An example of this includes the HbA1c Blood Sugar Monitor. Designed to empower diabetes patients with at-home HbA1c testing – revolutionising personal health management. Tape Specialities collaborated with ITERATE to design a groundbreaking diabetes self-management system. Furthermore, this device revolutionises how individuals monitor their health by enabling them to easily and regularly measure both their HbA1c and blood glucose (BG) levels anytime, anywhere.

Traditionally, individuals with type 2 diabetes are required to visit a clinic every six months for an HbA1c test as part of their care strategy. However, having the ability to measure HbA1c at home empowers individuals to take more proactive control of their condition.

This project exemplifies our ability to combine usability, manufacturability and compliance within one cohesive design process, guided by our RPD Pathway:

Foresight → Design → Prototype.

A Team Dedicated to Continuous Improvement

Retaining these certifications is a direct result of the dedication and collaboration of our talented team. Additionally, their attention to detail, commitment to robust systems and drive for improvement ensure that every project we deliver reflects ITERATE’s values of quality, innovation and integrity.

As Managing Director Gethin Roberts explains:

“Our ISO accreditations are more than quality marks – they’re a reflection of our culture. Every member of the team contributes to maintaining and evolving these standards, ensuring we continue to help clients bring meaningful, compliant, and commercially viable products to market.”

Quality That Powers Innovation

From Med Tech and wearables, to sustainable consumer products, every project at ITERATE begins and ends with quality. It’s what underpins our creativity, shapes our decision-making and empowers our clients to launch products that go on to make a measurable difference in people’s lives.

Quality isn’t just our goal, it’s what powers our innovation.

Next Steps

Finally, if you’re developing a new medical device or healthcare technology and want to ensure it meets the highest standards of design, safety and compliance, speak with our team today.

👉 Book a Product Strategy Call: https://iterate-uk.com/product-strategy-call/