ISO 80369-7 

Medical Luer Compliance

ISO 80369-7

Medical Luer Compliance

Services

Medical Device Engineering

Value Proposition

Engineering | ISO Compliance | Remediation

“Inceptive Design Group has helped several of our customers assess and comply with the newer ISO 80369-7 standards. They’ve been a pivotal conduit between our customers and our tooling/molding sites from program start to production validation. If you are in need of ISO luer expertise, don’t hesitate to reach out to IDG.”

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Brian Matachun

Vice President Sales, Healthcare - Westfall Technik

CHALLENGE

With ISO 594-2 being succeeded by ISO 80369-7, many medical luer device companies need help determining if their products comply with this new standard. IDG has been approached by a number of Westfall’s medical device customers to expedite an assessment, redesign (if necessary), and launch of new compliant luer designs.

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APPROACH

Equipped with our copy of ISO 80369-7, IDG typically performs a sprint of work spanning dimensional assessment of your luer component(s), a summary of findings and recommendations, and if necessary, updated 3D part geometry and 2D dimensioned prints to ensure compliance to the new standard.

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RESULTS

IDG has given a number of clients confidence that their medical luers meet ISO 80369-7 standards. In the instances where modifications were necessary, IDG has been pivotal in identifying and recommending the simplest changes relative to existing tool structures often limiting the expense for our customers.

Selected Works

Innovative Flip Phone CaseProduct Engineering and Design

NxT BIOMedical Device Remediation

Vero WaterNext Gen Bottle Cap

Westfall Technik / COVID-19Face Mask and Ear Relief Straps

ISO 80369-7Compliance