Quality Standards

Development and Manufacturing in IVD faces challenges resulting from:FDA logo ISO 13485

  • Globalization of operations and supply chains
  • Pressure to deliver products in the most cost effective manner possible.
  • The need to bring new concepts to market at an ever faster pace
  • Increasing customer expectations for superior quality

These challenges support the need for a high level Quality Management. Future Diagnostics is ISO 13485 certified and integrates its Quality Management System and Design Control Standards within every assay development and manufacturing project. Our research and development team is experienced in all phases of assay development, and we will make sure that every new product meets your highest performance standards. Future Diagnostics offers small to medium scale pilot and commercial production capabilities conform the cGMP guidelines for IVD. The Manufacturing Laboratory is a FDA registered site (FDA inspections in 2004, 2008,2011, and 2016).

We work according to the needed harmonized standards such as EN13612:2002, EN ISO 23640:2015 and applicable CLSI guidelines.


Quality Improvement Cycle

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