NOTE UK Achieves ISO 13485:2016 Certification: A Commitment to Quality in Medical Device Manufacturing
NOTE UK is proud to announce ISO 13485:2016 certification at our Basildon facility, reinforcing our commitment to excellence in medical device manufacturing. This internationally recognised standard ensures that our quality management systems meet the stringent requirements for the design, production, and servicing of medical devices.
Key Takeaways
- NOTE UK achieved ISO 13485:2016 certification, demonstrating our commitment to quality in medical device manufacturing.
- ISO 13485:2016 focuses on risk management, regulatory compliance, and process control, ensuring safety and reliability for patients.
- This certification assures customers that NOTE UK meets rigorous medical industry standards from PCB assembly to full box build.
- We incorporate ISO 13485 principles throughout production for traceability and robust documentation, supporting customers in product lifecycle.
- ISO 13485 is a promise of quality, safety, and reliability in our medical manufacturing capabilities.
Why ISO 13485 Matters
ISO 13485:2016 is the benchmark for organisations operating in the medical technology sector. It focuses on risk management, regulatory compliance, and process control—critical elements for patient safety and product reliability. By achieving this certification, NOTE UK demonstrates its ability to deliver high-quality, compliant solutions for healthcare customers.
What This Means for Our Customers
Our certification provides assurance that NOTE UK is a trusted partner in the medical supply chain. From PCB assembly to full box build, our processes are validated to meet the rigorous standards of the medical industry. This achievement complements NOTE Group’s wider commitment to quality, sustainability, and continuous improvement.
Our Approach to Quality
We integrate ISO 13485 principles into every stage of production, ensuring traceability, robust documentation, and strict adherence to regulatory frameworks. This enables us to support customers throughout the product lifecycle – from prototyping and development to full-scale manufacturing.
ISO 13485:2016 is more than a certification – it’s a promise of quality, safety, and reliability.
Learn more about our medical manufacturing capabilities and how NOTE UK can support your next project.