Medical device design & development (D&D) processes have never been easy to establish. Organisations have been searching for ‘templates’ or ‘ideal’ procedures to manage multiple projects, hoping to achieve a consistent output. Till current, more than 50% of companies still uses general document software to manage their medical device D&D. Such method is often insufficient to handle medical device development. The good news is there are electronic quality management system (eQMS) software in the market specially designed for medical device companies.