Regulatory Compliance and Quality
We ensure that our customers comply with best regulatory practice
At Congenica, the quality of our software and the insights it provides for patients is paramount.
In Europe, our software complies with HIPAA and GDPR requirements and is a CE Marked IVD clinical decision support platform for clinical diagnostic use in rare diseases as well as inherited and somatic cancers in the EU, Iceland, Lichtenstein, Norway, Switzerland, Turkey, and UK.
Regulatory Compliance and Quality are paramount
Regulatory compliance and quality are crucial for patient safety. To provide confidence in the effectiveness of our software, we follow strict quality guidelines throughout our organisation and our processes.
You can be confident that our software has been thoroughly validated as stated in our intended use statements, and trust us to continuously improve our products to ensure patient safety and product effectiveness.
As the regulatory landscape continues to evolve, we are committed to remaining ahead of the game with regards to meeting the strong requirements in our industry.
Jonathan Day Chief Regulatory and Compliance Officer, Congenica
Our commitment to regulatory compliance and quality
Standard
Title
ISO 27001
Information Security Management
EN ISO 13485
Medical Devices - Quality Management Systems
EN ISO 14971
Medical Devices - Application of Risk Management
EN 62304
Medical Devices - Software Life Cycle Processes
EN 82304
Health Software - Part 1: General Requirements for Product Safety
EN 62366
Application of Usability Engineering to Medical Devices
DBC0129
Clinical Risk Management
Our quality assurance