Design & Development

Disposable medical devices are deceptively complex. The limited availability of space within the anatomy and unique procedural applications prove to be significant challenges in all medical device developments. Next Medical Design, LLC, leverages its experience and in-house capabilities to realize a smooth and efficient product development process.

Our Prototyping Capabilities Include:
  • 3D CAD modeling from concepts to detailed design
  • CNC milling and CNC turning
  • Injection molding
  • Balloon bonding
  • Adhesive bonding
  • RF tipping & welding
  • Hot air bonding
  • Resistance welding

Medical Device Testing

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.

Common Testing Standards:
  • Mechanical test for verifying non-interconnectable characteristics of small-bore connectors (ISO 80369-1)
  • Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications (ISO 80369-3)
  • Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications (ISO 80369-6)
  • Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications (ISO 80369-7)
  • 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 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)
  • Syringe performance and flow characteristics (ISO 7886-1 & ISO 7886-2)
  • Performance Testing of Huber Needles for Coring of Port Septa (Journal of Medical Devices, Sep. 2010, Vol. 4 / 031008-1; ASTM F3212-16)
  • Sterile hypodermic needles for single use (ISO 7864)
  • Stainless steel needle tubing for the manufacture of medical devices (ISO 9626)
  • Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88)
  • Standard Test Method for Peel Resistance of Adhesives (T-Peel Test) (ASTM D1876)

Reference Connectors

We are pleased to offer Dimensional Verification and Certification of various Test Gauges & Reference Connectors according to their appropriate ISO 80369 standard. These include gauges from Alamo Gage.

All calibrations are performed with equipment complying with ISO17025 requirements.

For custom gauge verification or design and fabrication, please contact us at 919-844-6448 to discuss.

Please securely package & ship your gauges to:

Next Medical Design, LLC
ATTN: Laboratory
8817 Westgate Parke Drive
Unit 110
Raleigh, NC 27617

Video Measurement System

Video Measurement System

Figure C.1

Calibration of ISO80369-7:2021 – Figure C.1

$265.00

Female Reference Luer Lock Connector for testing Male Luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics

Select options
Figure C.2

Calibration of ISO80369-7:2021 – Figure C.2

$265.00

Male Reference Luer Slip Connector for testing Female Luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics

Select options
Figure C.1

Calibration of ISO80369-7:2021 – Figure C.3

$265.00

Female Reference Luer Lock Connector for testing Male Luer connectors for separation from axial load and resistance to overriding

Select options
Figure C.4

Calibration of ISO80369-7:2021 – Figure C.4

$265.00

Male Reference Luer Lock Connector for testing Female Luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics

Select options
Figure C.5

Calibration of ISO80369-7:2021 – Figure C.5

$265.00

Female Reference Luer Slip Connector for testing Male Luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics

Select options
Figure C.4

Calibration of ISO80369-7:2021 – Figure C.6

$265.00

Verification of ISO80369-7:2021, Figure C.6 - Male Reference Luer Lock Connector for testing Female Luer connectors for separation from axial load and resistance to overriding

Select options

Manufacturing

More information and details on this new service are coming soon!