medical device was confined to only apparatus, implants or objects but now medical device covers Software as well. Medical Device Software development makes life easier but comes with threats, such as data security, cybercrime, mismatched data etc. That’s why while developing a software it is very important to keep in mind what kind of devices the user will use mostly so that a SaMD are user friendly and shall be able to comply with the regulations of different countries worldwide.
medical device software development process
Step 1 – Planning
Step 2- Define the requirements
Step 3 – Design and prototype
Step 4 – Software development
Step 5 – Testing
Step 6 – Deployment
Step 7 – Operation and maintenance
Step 8 – Post-market surveillance
Operon Strategist are guiding new entrepreneurs and device makers for the regulatory compliance