Simplify ISO 13485 certification and ensure the quality of medical devices.

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Simplify ISO 13485 certification and ensure the quality of medical devices.

For safe and efficient medical devices

Specific to the medical device and related services sector, the ISO 13485 standard is essential to guarantee the continuous improvement of your activities and win the trust of your customers. You thus not only prove your ability to deliver safe and effective medical devices, but also comply with both regulatory requirements and those of your customers.

Lighten the complexity of the approach and benefit from a daily management tool

Optimiso software helps to design and simply communicate all quality documentation for medical devices. Its intuitive and interactive interface allows you to rally employees around this approach. The reporting of incidents is simplified, the tracking of improvements is facilitated, while indicator measurements are automatically collected.

An ideal ally for ISO 13485 certification

  • Simplified modelling and updating of processes and procedures
  • Management and assessment of risks related to the safety and performance of medical devices
  • Fast reporting of incidents and ease of complaint processing
  • Automatic creation of compliance matrices for monitoring regulatory requirements
  • Alert and automatic collection of indicator measures

Which modules for the quality management of medical devices?

The ideal graphic tool to easily model processes and procedures
Manage, archive, and easily view your internal documents
Effectively manage incidents, corrective and preventive actions, or improvement projects
Simply analyse and evaluate all your company’s risks
Identify, document and automatically track the implementation of controls
Easily define and assess employees competencies
Identify key indicators and automatically collect their measurements from employees