State-of-the-Art Software for Medical Devices
ISO 13485:2016 | FDA | EU | IEEE | IEC | ISO | AAMI
Our Quality System satisfies the requirements of these major standards:
- ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
- IEC 62304:2006/AMD1:2015, Medical Device Software – Software Life Cycle Processes
- FDA’s General Principles of Software Validation (GPSV)
- IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product lifecycle
- ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices
- ISO/IEC 12207, Systems and Software Engineering – Software Life Cycle Processes
- FDA CFR Part 820, Quality System Regulation
- Good Automated Manufacturing Practice (GAMP)
- International Society of Pharmaceutical Engineering (ISPE)
- EU Medical Device Directive (91/42/EEC)
