Regulated Development Process
Affinial has been developed as a medical device in accordance with ISO 13485, IEC 62304, ISO 14971, and ISO 27001 Information Security Management System in the areas of support and delivery of cloud-based systems by Managed Service Operations business to expedite regulatory approval of custom solutions.
Regulated Solution Operation
To reduce burden on our life sciences partners, solutions created on Affinial can be operated under our ISO 13485 and ISO 27001 Information Security Management System in the areas of support and delivery of cloud-based systems by Managed Service Operations business certifications. We also perform maintenance, reporting, risk and change management services.