"Most risk management engineers use Excel tools to manage their FMEAs worksheets. The biggest challenges are that those FMEA worksheets need frequent updates triggered by customer complaints, CAPAs, NCMRs, and annual reviews. However, this process is timely and labor-intensive, leading to delays in response time and traceability. RdPDM software uses electronic FMEA worksheets and reports to facilitate easy, quick, and traceable changes. It estabishes a risk management system based on FDA Hazard codes, covering pre-market, new product development, and post-market surveillance which reduces conflicts and enables smooth communication with regulatory agencies. This application helps us to eliminate non-value added activities and encourages proactive risk prevention. The application creates seamless integration between post-market surveillance and risk management files, making it easy to observe and address any gaps."
John Spanomanolis, Risk Management Consultant
Abbott, Sylmar, CA
"The RdPDM software is a comprehensive tool designed to assist project managers in planning and tracking deliverables throughout the project life cycle. It provides an efficient platform for collaborations within cross-functional teams. The Dashboard allows project managers to quickly overview the project status and post notices. I believe this tool is a great asset for project managers and their teams."
Jingjing Li. Project Manager
BD, San Diego, CA
"I am impressed with the tool's features. It enables project teams and project managers to monitor their projects from initiation to completion. The application provides a list of deliverables that can be sorted by stages of development, as well as filtered to show incomplete, in-process, and completed deliverables. Additionally, it allows you to view pre-requisite items required for each deliverable. The dashboard feature allows for the creation of a project overview, providing a clear view of the project status. The project roadmap is particularly helpful in planning project activities, and it can be modified and viewed at any time. Moreover, the tool is easy to maintain and update, accomodating the addition or deletion of deliverables as necessary."
Myra Barrera. Quality Project Manager
BD Carefusion, San Diego, CA
"I believe both our companies will greatly benefit from this decision to use the RdPDM software. We look forward to working together towards announcing the successful outcome of our first product, developed with the QA/product development plan and system RdPDM has created."
Adrian Pelkus. CEO
Blue Moon Medical, Inc. San Marcos, CA