13 May Is Your Design on the Road to Success? (Part 1 of 4)
Do you have a design partner?
In this series of articles , we asked the following four questions to help our readers determine whether their design is on the road to success:
- Before you begin formal development, do you know exactly what your product will look like, how it will function, and how it will handle fault conditions?
- Do your processes allow you to efficiently make changes to designs while meeting FDA and international regulations?
- Do the tools your company uses for development, documentation, configuration management, verification, and complaint-handling work well with your processes?
- Does your company have a partner that can help you anywhere in your development cycle, from concept through design transfer, from usability to risk management, from process development and improvement to test lab preparation?
This article will focus on the last question, “Does your company have a partner that can help you anywhere in your development cycle, from concept through design transfer, from usability to risk management, from process development and improvement to test lab preparation?”
No matter where we are in our careers, it’s good to have somebody to talk to, a mentor or peer who may not have all the answers but who can help you find them. A coworker with one area of expertise can sometimes benefit from the knowledge of another with a different skillset. Sometimes it’s just good to vent. Companies are similar. Just as a coworker brings a different perspective to a problem, a design partner brings the perspective of its people and experience to the problem.
Realtime has been helping customers in the regulated spaces through every stage of development for over 15 years .Our management team averages over 30 years of experience in R&D and Quality in regulated industries. We’ve taken napkin sketches and made prototypes of them. We’ve taken prototypes and made products of them, including cost reduction and design transfer. We’ve taken existing products and helped our customers prepare them for compliance testing such as IEC 60601. We’ve helped customers establish FDA– and internationally-compliant processes where none existed before. We’ve helped with V&V efforts and risk and requirements management. We’ve helped customers remediate compliance issues and product performance issues. These are our areas of expertise. Let our expertise help you do what you do best: design products to help the world.
Our customers range from small startups to Fortune 500 companies, come from several different countries, and market worldwide. Industries represented include medical, oil and gas, defense, consumer electronics, and aerospace. While we may not know everything about everything, we may be able to recommend someone from our large network of trusted resources that can help you with what you need. We have the experience. We can help. Give us a call today at 972 985-9100.