Sivak Associates Quality Elevated
Excellence is an art won by training and habituation. We are what we repeatedly do. Excellence, then, is not an act but a habit.
Aristotle
What we do
Global Medical Device / Invitro Diagnostic Quality Regulations / Requirements
Let us help you meet global medical device / invitro diagnostic quality requirements including ISO 13485:2016 Quality Systems, ISO 14971 Risk Management, 21 CFR 820 QMSR 2024 US FDA, and IEC 62304 Medical Device Software Life Cycle requirements.
Quality Management Systems
Develop and implement risk-based quality management systems that meet global requirements of the geographies you are targeting.
Software Validation
- Medical device / IVD software validation including planning, documentation and protocol execution for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD).
- Quality and Production software validations that support medical device manufacturing and may affect quality. (GxP)
- Software quality assurance activities including design review, peer code review, test planning and execution
- Labeling and promotional review and claims substantiation.