Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease.
To innovate clinical diagnostic approaches for improved delivery, reduced costs, and better patient outcome.
Empowering practitioners to make informed clinical decisions for improved patient outcomes.
SpeeDx Quality Policy
SpeeDx has a quality mission to consistently meet the needs and expectations of customers, commercial partners, and regulators in the following way:
SpeeDx will comply with ISO 13485, IVDD (EU), QSR (US FDA), MDR (Health Canada), TGR 2002 (Australian TGA) and any other regulatory requirements as they arise; our Quality System effectiveness will be reviewed and maintained by management.
SpeeDx will endeavour to improve the health and safety of customers by continuing to invest in product development activities with the aim of producing in vitro diagnostic medical devices and research use only products for the detection of nucleic acids.
A company-wide culture committed to quality will be supported by management with the establishment and continuous review of quality objectives.
Achievement of this goal involves all staff, each of whom are individually responsible for the quality of their work, resulting in a continually improving work environment and a continually improving Quality Management System. Management at every level has an additional responsibility to ensure quality is instilled in all levels of the organisation, and in all activities.