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next medical design, LLC is an international medical device development company serving clients worldwide and offering all inclusive project management for the device industry, including:

· Device design and development

· Regulatory approval coordination

· Product testing and validation support

· Knowledge transfer to manufacturing partners or direct to your production facility

Other services provided:

· Consulting and freelance design

· Tensile, compression and various other verification tests

· Technical support for client managed projects

What makes us different Philosophy for the most efficient product realization:

· Hands-on development by the Principals for quick and smart decision making

· Broad reach into all aspects of development and production transfer processes to maximize communications and efficiency

· Focus: two or three projects run concurrently, maximum

Quality Management System:

· Captures design history early

· Easy knowledge transfer to regulatory submissions, DMRs, manufacturing documentation and ERP systems

· Built to ISO 13485 and FDA CFR 820 guidelines

We provide international work in English or German languages.

Here a few examples of products developed by next medical design, LLC:

· Central Venous Catheters

· Emboli Protection Catheters

· Stylets, designed for electrical induction

· Percutaneous Sheath Introducers

· Endoscopy Biopsy Catheters

· Hemodialysis Catheters

· Balloon Catheters

· ...

next medical design, LLC offers laboratory services according to ISO, EN and ASTM standards as well as FDA Guidance Documents to confirm your product’s performance or benchmark analysis:

· Test for tensile properties (EN 1618)

· Force at break (ISO 10555-1, ISO 11070)

· Kinking test of tubing (EN 13868)

· Test for security of connectors / Determination of strength of unions (EN 1618, ISO 10555-5)

· Test for determining the security of fit of a drainage funnel (EN 1616)

· Test for strength of union of core wire and coil of guide wire / union of coil and safety wire (ISO 11070)

· Test for freedom from leakage and damage on inflation (Balloon Dilatation Catheters) (ISO 10555-4)

· Test of bond between hub and needle tube (ISO 7864)

· Patency of needle lumen (ISO 7864)

· Mechanical tests for verifying non-interconnectable characteristics of small-bore connectors (ISO 80369-1)