Swiss IT company seeks quality management

We are an IT company (software development) and are looking for quality management software for medical technology. For the management of our QM system, we are looking for software that meets the following requirements:

• All QM tasks (such as document control)
• Support for QMS standard ISO 13485
• CAPA process (corrective and preventive action)
• Audit process
• Risk
• Traceability matrix
• DHR (Device History Record), DHF (Design History File), and MDR (Medical Device Regulation)
• Compliance and data security
• Updating of nomenclature
• Scheduling of audits and CAPAs
• Management of QM
• We must cover the following standards
• Title 21 of the U.S. Code of Federal Regulations Part 820 (21CFR820) “Quality System Regulation” and Parts 803, 806, 807, 812, as applicable
• EN ISO 13485:2016 “Quality Systems-Medical Devices Particular Requirements for Regulatory Purposes”
• Health Canada “Medical Device Regulations” (SOR/DORS)
• EN ISO 14971:2000 “Medical devices - Application of risk management to medical devices”
• EN ISO 9001:2016 “Quality management systems - Requirements”
• IEC 62366 USABILITY ENGINEERING PROCESS
• IEC 62304 Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
• IE 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety including essential performance - Collateral standard: Usability - Edition 02.2016

Approximately 30 software workstations are planned. Work will be carried out in an MS Windows system environment.