What you need to know about ISO 80369 as a player in the medtech market
- What is ISO 80369
- The ISO 80369 is a series of standards that specify unique international standard designs of small-bore connectors for various clinical applications to ensure that connectors for unrelated delivery systems are incompatible. These clinical applications are; breathing systems and driving gases, enteral and gastric, limb cuff inflation, neuraxial devices and intravascular. Changes for the new standard connectors will roll out by delivery system and will be communicated with advanced warning so that all parties can prepare for the changes in the market.
- What ISO 80369 means for the market
- It is up to the industry to decide whether it wishes to implement these standards. While ISO standards may be adopted in some countries as part of their regulatory framework, or referred to in legislation for which they serve as the technical basis, such adoptions are decisions by the regulatory authorities or governments of the countries concerned. ISO itself does not regulate or legislate.
- If manufactures fail to innovate, and adapt to the new standards, one or more of their product lines may become obsolete, which in turn may dramatically impact their market position.
OVERVIEW OF ISO80369
Brought to you by Synecco
Synecco is perfectly posed to assist companies to achieve not only regulatory approval and market launch in light of the development of ISO 80369 standards, but transform this market into an opportunity for growth.
Synecco founded in 2004 and located in Galway, is a global supplier of world-leading contract manufacture and design solutions for the medical device market. Synecco have proven to be the partner of choice for many medical device companies seeking design and engineering, component manufacture and assembly, as well as supply chain management solutions. Synecco is fully compliant to industry standard ISO 13485 and is focussed on developing and supplying innovative medical device solutions for our partners. Synecco has a diverse commercial client portfolio, from large MNC’s to well-funded start-ups.
For more information, visit www.synecco.com