Managing D&D Efforts

Our experts can manage your Design and Development (D&D) efforts to help ensure that your medical device meets regulatory agency requirements and standards.  Contact us to see if AZ Technica is the right match for your team. 

Early Design Planning

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

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 to the contract manufacturer. 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 and a critical eye,  helping you identify potential issues early in the design process. In addition, we can help identify whether you can leverage the contract manufacturer’s Quality Management System (QMS) or if it is time to start implementing a “light” internal QMS. 

Initiating a Company QMS 

   During D&D it is important to have a right-sized system to manage any documentation that is generated in a controlled manner. This could be in the form of an internal Quality Management System (QMS), or simply designating your contract manufacturer as the repository for these documents. We can help teams navigate this decision-making process to make sure you are in compliance, but not over-complicating the project too early. 

Premarket FDA Communications 

We are proponents of having an open dialogue with the FDA during design and development efforts. Early conversations with the FDA can save teams significant amounts of time and money, ensuring that later submission materials are aligned to FDA expectations. Regardless of the type of Q-Sub you want to submit, we can help craft the communication to get your relationship with the FDA off to a smooth start.  

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 pull together the documentation needed for new device regulatory submissions. We provide fast and efficient organization of filings both nationally and globally.