Medical Device Standards
Psyomics is committed to delivering diagnostic tools and research services in accordance with ISO 13485:2016, EN 62304, ISO 14155, ICH GCP and the Medical Device Directive 93/42 EEC, and to following other regulatory ISO standards where appropriate.
Psyomics holds the ISO 13485 certification. This certification is an international standard for quality management within the medical device industry. Achieving this certification demonstrates our commitment to delivering diagnostic tools that meet safety and quality requirements.
Psyomics holds the ISO 27001 certification. This is an internationally recognised standard of Information Security Management. Psyomics operates an Information Security Management System that complies with best practice and protects users and their data.
Psyomics has achieved the level of Cyber Essentials Plus, assessed by IT Governance Ltd as meeting the requirements of cyber security.
Data security is one of our core concerns. We believe that the trust our customers place in us is a privilege and we are committed to upholding the highest levels of data management and protection.
Psyomics complies with GDPR regulations and is registered with the ICO with robust policies and procedures in place to ensure continued compliance with the relevant standards. Data collected on individual users of any of our products is designed with a high level of protection and stored securely. Tools developed for third-parties, such as the Delta Trial, are designed to the same high standards, but any personal information collected is only held and accessible by the researchers at the University of Cambridge running the trial. We do not have access to this information at Psyomics.
GDPR is the new EU regulation regarding data and privacy and goes far further than the Data Protection Act in protecting people’s rights. Our statement on GDPR can be found here.