VALIDACIÓN IQ/OQ

Para las compañías farmacéuticas y de dispositivos médicos, la validación del software es fundamental para el cumplimiento de la FDA 21 CFR Parte 820, también conocida como Regulación del Sistema de Calidad (QSR) e ISO 13485. Los Servicios Profesionales de Instron® han proporcionado servicios de documentación y validación in situ para respaldar Calificación de instalación / Calificación operativa (IQ / OQ) y validación de software durante muchos años. Este servicio, provisto por el fabricante del equipo original, está diseñado para garantizar que su equipo de ensayos Instron sea adecuado para el propósito previsto y capaz de producir resultados válidos.

  • Services
  • 6/4/2020
  • 0.9 MB

Automated XY Stage Testing System

The Instron Automated XY Stage Testing System is designed for automated testing of devices or components with multiple test points such as medical devices, syringes, or keypads. The XY stage easily mounts to a 6800 or 5900 Series testing frame. Instron’s Bluehill Universal Software offers complete system control in one package: XY stage movement, method development, test control and results.

  • Products
  • 5/21/2020
  • 430.5 KB

ElectroPuls 16-Station Testing System

ElectroPuls 16-station fatigue fixture allows the simultaneous testing of up to 16 specimens to drastically reduce total test times and help deliver products to market sooner. Medical devices, such as coronary stents, require multiple successful results over hundreds of millions of cycles in order to ensure decades of safe operation and gain FDA approval.

  • Products
  • 5/20/2020
  • 0.8 MB

CEAST TUP Calibrations

Instron professional services are now accredited to carry out on-site NVLAP calibrations for gauged TUPs under 100kN. This calibration can be carried out on your machine thus minimising the amount of time your equipment is down and enabling you to be back up and testing in only a few hours.

  • Services
  • 5/7/2020
  • 0.9 MB

Torsion Add On 2.0 for Electromechanical Systems

The Instron® Torsion Add-On 2.0 for Electromechanical Universal Testing Systems is designed for simple, simultaneous axial and torsional testing of devices and/or components, but has the flexibility to be used for purely uni-axial or torsional testing.

  • Products
  • 4/30/2020
  • 1.8 MB

2501 Series Compression Platens

The compression platens are used to perform compression tests on a wide range of materials and components. This allows a variety of tests to be performed for determination of compression modulus, compression strength, and compression yield strength.

  • Products
  • 4/30/2020
  • 252.8 KB