Post Market Support

Once your device is on the market, AZ Technica can help ensure your device meets ongoing safety requirements and identify potential issues. Contact us to see if AZ Technica is the right match for your team. 

Implementing Full QMS

 Once your device is cleared for the market, your team will need to roll out a full Quality Management System (QMS). We can help update and expand your current QMS or provide insight for appropriately sized QMS software. Depending on your identified markets, we can provide QMS expertise for ISO 13485:2016, ISO 9001:2015, 21 CFR 820, QMSR, EU MDR, and more.  

Audits

 Internal and external audits can feel overwhelming, but they also provide critical information about the health of a company’s QMS. We offer virtual support for both internal and external audits. For internal audits, we will assess your company’s QMS, and document compliance with SOPs, ISO 13485, and applicable regulations specific to your device.  We provide you with a report that describes any nonconformances or opportunities for improvement. Were you notified of an upcoming external audit? We can help. Similar to internal audits, we can help prepare the company, recommending steps to be taken prior to the audit. We can also help your team identify appropriate corrections and corrective actions for any previous audit findings. 

Device Design Updates

 As your medical device is on the market, your team will identify changes that need to be made to the device. Sometimes these changes seek to improve the safety and performance of the device; sometimes these changes are due to supplier curveballs. Your company will need to roll out such changes in a controlled and prescribed manner. We’re here to help! We can guide your team through the process and help determine if the device changes require regulatory submissions.  

FDA and Regulatory Body Communications

 Once your device is on the market, your team will become one of the most important watchdogs of that technology. Post Market Surveillance will help your team collect data on the safety and efficacy of the device while it is on the market. We can help your team understand what and when information needs to be reported to regulatory bodies. Let us help you maintain a clear and effective communication channel with the FDA and other regulatory bodies. 

Training  

AZ Technica offers several training options including onsite or remote learning. Training programs are customized to your specific needs and are led by industry experts. We make sure your team’s knowledge is aligned with current standards, guidance documents, and best practices. 

Popular training topics include:

Quality Management Systems (ISO 13485:2016 or ISO 9001:2015)

Risk Management (ISO 14971)

EU Medical Device Regulation (2017/745)

Design Controls

Post Market Surveillance Requirements

Production and Process Controls

Technical Documentation