Medical Devices Industry

Knyo makes it easy for all medical devices manufacturer to follow regulatory compliance as defined by ISO and FDA.

Challenges

  • As we move into the future after the pandemic, medical device manufacturers may face new opportunities as well as challenges.
  • We all have witnessed in the pandemic that there was tremendous stress on this industry while meeting increased demand.
  • Medical equipment manufacturers are facing a competitive condition as new standards and regulations are becoming more complex and health care dynamics are changing frequently.
  • Producing devices that can be used around the world under different operating conditions is challenging.

Solution

Document management

Knyo offers simplified documents management for standard operating procedures (SOPs), device history files (DHFs) and device master records (DMRs).

Regulations & compliance

Document management platform is fully compliant with regulatory standards like FMEA, GMP, FDA, EPA ...

Custom workflows

Knyo drives your innovation through controlled custom workflows that share data and documents amongst different entities in the organization also streamlines the regulatory compliance process.

Quality management

Quality and cost are maintained by facilitating the immediate rectification of defects, or by continuous improvement.

Change management

Implement convenient and flexible change management suitable for your product development in Knyo.

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