ENFit ISO80369 Solution

Category: Quality & Regulatory support
When standard change, those that adapt first can steal market share

By early 2015, ISO 80369 began to force the enteral and gastric market to adopt a connector that is non-interconnectable with the traditional leur type. Synecco proactively developed a programme to manage the technical, regulatory and inventory challenges of our client’s transition. Our responsiveness turned a potential supply threat into a reputation enhancing opportunity and allowed our client to establish itself to become a market leader in the enteral market.

Through  Synecco’s support, the client company adopted the new ISO 80369 regulations and launched a range of devices into the market. Synecco also helped in generating IP across a range of devices and managed the supply chain for the client during the regulation change period.

Following this work with the new ISO 80369 standard, Synecco are perfectly poised to assist companies who will be required to change connectors in those areas identified by regulators including:

  • breathing systems and driving gases applications (oxygen and ventilators)
  • enteral applications (feeding tubes and formula delivery systems)
  • urethral and urinary applications
  • limb cuff inflation applications
  • neuraxial applications (spinal and epidural catheters and infusions)
  • intravascular or hypodermic applications