ISO 13485 Electronics Manufacturing – Not just for medical devices

 “A complete quality management system, benefiting all our clients”

ISO 13485 electronics manufacturing from 4e

4E Technology are proud to hold the ISO 13485 Electronics Manufacturing international standard of quality for the manufacture of medical devices, demonstrating our long-term commitment to quality medical products and their development. The ISO 13485 standard helps ensure robust quality management in the design and manufacturing of medical devices within this highly regulatory market. 4E believes that this benefit and its processes should be applied to all our products such as, consumer, defence and aerospace alike.

We offer a highly compliant service with New Product Introduction (NPI), Continuous Improvement (CI) and Design for Manufacture (DFM) support. With over 20 years electronics experience we can often add value to a project by identifying opportunities for cost reduction, improved supply chain and performance improvement, without ever compromising on a client’s quality requirements.

What does ISO 13485 electronics manufacturing certification bring to our clients?

  • Robust supply chain management with full traceability and extensive Approved Suppliers.
  • Reinforced commitment to quality.
  • Greater Risk Management.
  • Stringent change control processes.
  • Scalable manufacturing – Prototyping through to Volume Manufacture.
  • Progress is tracked and verified.
  • Manufacturing documents and processes that ensure a client’s product satisfies regulatory requirements.

The ISO 13485 electronics manufacturing quality regulation is an asset to all our clients, providing them with confidence that not only do we deliver on time, on budget and to quality, but with all the regulatory boxes ticked.

Contact the team at 4E today to discuss your project or to request a quote.