Cloud Based Continuous Quality and Compliance
Total Product Life Cycle (TPLC) Management Software
For Medical Device Software and SaMD
Automate the entire FDA compliance process through
Quality Management System (QMS),
Application Lifecycle Management System (ALM),
Risk Management System (RMS) and
Good Machine Learning Practice (GMLP)
For Quality and Risk management, Medical Device Hardware & Software (MDHS) and Software as Medical Device (SaMD) Manufacturers depend on the guidelines of ISO 13485 and ISO 14971 respectively, although they need interpretation, implementation, and enforcement specific to the software and hardware specific needs. Additionally, the manufacturers need to follow IEC 62304 for guidelines on Software Development Lifecycle (SDLC) or Application Lifecycle Management (ALM). For the Agile minded development teams, the guidance on Agile Practice for medical device software described in the document AAMI TR45 will be especially useful.
MediDev’s MDHS Lifecycle Management implements all aspects of Quality, Risk, and software development lifecycle management for Medical Device Hardware & Software and SaMD tightly integrated. The best practices following the guidance described in all the above documents come out of the box ready to use on day one. However, if needed MediDev includes the drag and drop configurability for any organization to customize the processes to their exact needs.
Learn more how MediDev MDHS Lifecycle Management helps in MDHS and SaMD development, pre- and post-approval processes.