RA, QA, and Engineering

AZ Technica can provide expertise in Regulatory Affairs (RA), Quality Assurance (QA), and Biomedical Engineering. Contact us to see if AZ Technica is the right match for your team. 

Regulatory Affairs

 Regulatory Affairs expertise makes sure that your company and device are compliant with applicable regulations and standards, including ISO 13485, EU MDR, and 21 CFR 820. Our team can prepare and submit the regulatory submissions such as 510(k) submissions, De Novo classifications, or Premarket Approvals (PMAs). We also offer post-market support once your device is cleared for the market.

Quality Assurance

 Quality Assurance helps ensure that devices remain safe and effective by establishing processes throughout the device lifecycle, helping identify and manage the risks associated with the device. Quality Assurance is built into every fiber of a medical device company through the roll out of a mature and well-functioning Quality Management System. Our team can support individual quality assurance projects as well as help implement a QMS that keeps quality front and center at your company. 

Biomedical Engineering

 Before prototypes are finalized at a design house, we can review your device specifications to verify the documentation is complete and sound. We look at early device renderings through the lens of RA/QA and biomedical engineering, examining your design specifications and providing recommendations as needed. Although we are not device designers, we take pride in making sure your medical device smoothly transitions from design house to contract manufacturer.