Managing D&D Efforts

Early Design Planning

Have an idea – don’t know where to start? We can help. With minimal intervention, we can help you define your device and find a right-sized team to build your prototype. This work will help you get through Proof of Concept and prepare you for conversations with potential contract manufacturers.

 Setting up your QMS 

 Even if you plan on being the legal manufacturer of your device, you shouldn’t need a heavy Quality Management System (QMS) right out of the gate. Get personalized help from our team to develop your QMS so that it can grow alongside your company.  Depending on your identified markets, we can provide QMS expertise for ISO 13485:2016, ISO 9001:2015, 21 CFR 820, FDA, QMSR, and more. We firmly believe that a right-sized QMS will help your organization to thrive by minimizing premature roadblocks.  

Managing D&D Activities

Once you have a viable prototype, you will likely work with a contract manufacturer to move through design controls. However, many startups are frustrated to find out that their project loses momentum when the project is handed off. We support team efforts by managing project schedules and action items, helping keep your project front and center with your contract manufacturer. We also provide outside expertise, helping you identify potential issues early in the process so that controls can be put into place.

Regulatory Submissions

Once you have moved through design controls and have your final device in hand, we can help you present the device to regulators. Our regulatory consultants can help your team with new device regulatory submissions. We provide fast and efficient organization of filings both locally and globally.