Regulatory

ISO Certifications

ISO 9001 and ISO 13485In 2011 Psychology Software Tools, Inc. achieved ISO 9001:2008 certification for the design, development, production, assembly, installation and servicing of products and tools for psychology research, assessment, and education.

In 2008 Psychology Software Tools, Inc. achieved ISO 13485:2003 certification for its quality management system related to the design, development, production, assembly, integration, installation, sales and servicing of computerized systems, specialty equipment, and hardware/software accessories for human clinical assessment of psychological, physiological, and neuropsychological function using computerized stimulus presentation, accuracy and response time measures, MRI/fMRI, EEG/ERP, MEG, fNIR, and related techniques.

ISO (International Organization for Standardization) is the world’s largest developer of standards that contribute to making the development, manufacturing, and supply of products and services more efficient, safer, and cleaner.¬† ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable¬† statutory and regulatory requirements. ISO 9001:2015 certification ensures that companies provide medical devices and related services that consistently meet customer and regulatory requirements. In order to obtain this certification, PST has demonstrated its ability to successfully implement a comprehensive management system that meet these regulatory requirements.

ISO 9001:2015 Certificate

ISO 13485:2016 Certificate