We add value to our customer’s projects by providing specialized regulatory compliance expertise, broadened capability through industry partnerships, turn-key design capability, and seasoned program management solutions that accelerate development.
Several of our customers have only a concept, requirement, or use-case, and need us to take that idea all the way through to an affordable transfer-to-manufacture. These customers need a design firm who understands that technical challenges are only a fraction of the risks associated with a turn-key design project. Design/build projects often incur unnecessary costs and schedule delays during the transfer-to-manufacture process.
We pro-actively work with the selected manufacturer / final assembler (whether customer-directed or one of Realtime’s trusted partners) to understand their design guidance for manufacturability, deliverable formats, supply-chain preferences, and factory testing capabilities. Following a “design with the end in mind” approach, we can significantly reduce risk and cycle time during the manufacturer’s New Product Introduction (NPI) process.
Design for regulated products means managing the balance between creativity and rigor. This can be particularly costly when implementing the required process controls for the first time, while your engineering team resolves design challenges. Seemingly innocuous process or design choices can later cause costly documentation rework, DHF remediation, missteps during verification tests, or rejected regulatory filings.
Realtime’s seasoned staff brings numerous projects cycles of helping customers manage this very problem, having seen the good, bad and ugly across a variety of projects. We know how to work with your QA and Regulatory Compliance teams, to produce the right evidence and artifacts that they can move through the process without becoming overwhelmed with unnecessary documentation.
Risk is the effect of uncertainty, and all development projects have to deal with uncertainty. How organizations and their suppliers deal with risk has become a growing concern for regulatory compliance. The current version of the ISO 9001:2015 Quality Management System (QMS) raises the bar on incorporating risk-based processes as a reaction to their analysis of trends.
As a design services provider, we have found that our Customers depend upon us to come already trained, practiced, and competent at Risk-Based Thinking (RBT). They need for us to be able to demonstrate that pro-active risk management is already incorporated at the leadership-level, but even more importantly, our Customers often need us to bring proven process solutions to their projects that can mitigate implementation costs.
Realtime provides several related assistance solutions, gap analysis, sample processes, training, including implantation best-practices, and documentation templates that can make RBT a benefit to your performance.
Running out of project funding practically guarantees an unsuccessful result. As obvious as it sounds, the services model was invented for customers who need a specific capability for a defined period of time, but don’t want to have to pay to keep it maintain it when they don’t need it. Too often, Services companies are motivated to extend the business engagement until financial resources are consumed.
Realtime’s growth is fueled by the successes of our Customers, and we understand that the only path to success is a commitment to finishing the task at hand, no matter whether that task is a simple trade study, or a complex turn-key design.