About INO

Certifications and Quality

In order to provide products and services matching your expectations, INO is constantly improving. INO holds certifications and applies the latest version of many standards and references. 

INO is also certified for medical devices development and production.

Certifications

Conformités

  • Applicable standards related to Electrical and Laser Safety
  • PMBoK-PMI - Project Management and INCOSE – Systems Engineering

  • ISO 14644 - Clean Rooms

  • ANSI S20.20 - Electrostatic Discharge (ESD) Protection

  • Environmental testing compliant to many standards, such as US military standards (MIL-STD) and equivalent

  • Support for CE Marking and European Directives (partial list) :

    • MDDMedical Device Directive 

    • CE Marking – Directive

    • EMC – Electromagnetic Compatibility Directive 

    • RoHS – Restriction of the use of certain Hazardous Substances Directive

    • WEEE – Waste Electrical and Electronic Equipment Directive

    • LVD – Low Voltage Directive

    • MID – Measuring Instrument Directive 

    • REACH – Registration, Evaluation, Authorization and Restriction of Chemicals 

Medical Devices Development and Production

  • Processes and tools including Management of Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR)
  • ISO 14971 - Medical Devices - Risk Management

  • IEC 60601-1 - Medical Electrical Equipment-Security and Performance

  • IEC 62304Medical Device Software

  • ISO 10993-x – Biological evaluation of medical device

  • Support to regulatory aspects and product certifications for Health Canada, the FDA, CE marking, and others

  • Any other agreed standards or references within the scope of work

What are your needs?

What are your needs?

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