Transition completed to ISO 13485 medical device accreditation

5th March 2019
Posted By : Anna Flockett
Transition completed to ISO 13485 medical device accreditation

Global Electronics Manufacturing Services (EMS) specialist Chemigraphic has successfully transitioned to the new 2016 version of the medical device manufacturing standard, ISO 13485.  This transition reflects Chemigraphic’s strong standing within the medical arena, where it works with world-leading medical OEMs such as Varian and Elekta.

Medical technology
In 2018, Elekta’s Unity Linac machine, which delivers a cancer treatment service combining radiotherapy with MRI technology, achieved CE status and was launched into the global medical market. Chemigraphic was involved in the design, development and assembly of the machine’s electronics from concept to delivery.

John Johnston, NPI and Sales director, Chemigraphic, commented: “It’s a huge privilege for us to be involved with some of the most pioneering medical projects in the world, something we take great pride in. In order for us to deliver the very best for our customers, it’s vital that we take quality and processes extremely seriously. Standards such as the ISO 13485:2016 are an excellent mark of our commitment to quality, allowing us to credibly demonstrate our excellence in medical electronics manufacturing.”

Upgrading performance
ISO 13485 is the official standard for ‘Quality Management Systems for Medical Devices’, requiring certified organisations to meet minimum levels of excellence and quality in the manufacture of medical devices. To transition from the original standard to the 2016 version, companies are required to demonstrate and validate excellence in a number of areas, including:

  • Quality management systems
  • Risk management measures
  • Record keeping
  • Validation of processes
  • Compliance with relevant regulations
  • Effective product traceability
  • Comprehensive complaints and returns handling procedures

Key differences in the new 2016 standard include: strengthened requirements around purchasing and supplier monitoring; extended compliance with all regulatory requirements; applying a risk-based approach to operations and updated record-keeping requirements.


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