ISO 13485 - Advanex

ISO 13485: Medical Device Quality at Advanex Europe

Precision Engineering for the Most Demanding Applications

At Advanex Europe, quality is not optional—it’s essential. That commitment is reflected in our certification to ISO 13485, the internationally recognised standard for quality management systems in the medical device industry. This certification demonstrates our ability to consistently meet regulatory requirements and customer expectations in the design and manufacture of components for medical and pharmaceutical applications.

What is ISO 13485?

ISO 13485 is a globally accepted quality standard designed specifically for organisations involved in the lifecycle of medical devices, including design, production, installation, and servicing. It provides a framework for risk management, traceability, process validation, and regulatory compliance.

For our customers, ISO 13485 ensures that Advanex Europe is a reliable partner capable of delivering components and assemblies that meet the highest standards of safety, performance, and consistency.

Our ISO 13485-Certified Capabilities

At our Southwell facility in the UK, Advanex Europe maintains full ISO 13485 certification. This site is equipped to support a wide range of precision-engineered components and assemblies used in critical medical and pharmaceutical applications.

Our capabilities include:

Design and development of precision springs, wire forms, and insert mouldings for medical devices
Cleanroom manufacturing (ISO Class 7) for contamination-sensitive applications
Process validation, traceability, and rigorous quality control
Regulatory compliance and documentation support
Rapid prototyping and product optimisation in collaboration with medical OEMs

From high-volume production to low-volume, high-complexity development, we provide the flexibility and expertise that medical device manufacturers need in a regulated environment.

Commitment to Regulatory Compliance

ISO 13485 aligns with many global regulatory frameworks, including:

UK MHRA requirements
EU Medical Device Regulation (MDR)
US FDA 21 CFR Part 820

By operating under ISO 13485, we ensure that every part we deliver supports your own compliance obligations and risk management requirements.

We follow strict protocols for design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and process qualification (PQ), which are essential for regulated industries such as medical, pharmaceutical, and diagnostics.

Why ISO 13485 Matters to You

Working with an ISO 13485-certified supplier gives you:

Confidence in quality and process control
Reduced supplier risk for audits and inspections
Full traceability of materials, processes, and documentation
Greater speed to market through proven design and validation systems
Assurance that your supply chain meets industry-specific compliance standards

Integrated with Our Broader Quality System

Our ISO 13485 certification is part of a fully integrated quality and compliance framework that includes:

ISO 9001 – Quality Management
ISO 14001 – Environmental Management
ISO 45001 – Occupational Health & Safety
AS9100 Rev D – Aerospace Quality Management

This integrated approach ensures alignment across all operational areas, reducing complexity for our customers and delivering consistent performance at scale.

Supporting You Through Every Stage

Whether you’re in the early stages of a product concept or scaling up production of an established device, our team of engineers and quality specialists is here to support your journey.

We collaborate closely with your design, procurement, and quality teams to:

Streamline component integration
Optimise performance and durability
Accelerate development timelines
Ensure audit-ready documentation and traceability

Work With a Certified Partner You Can Trust

Advanex Europe is proud to support some of the world’s most innovative medical and pharmaceutical companies with compliant, high-precision components engineered for safety and performance. Our ISO 13485 certification is more than a standard—it’s a foundation for lasting partnerships built on trust, reliability, and shared quality goals.