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Industries We Serve

Medical Devices and Diagnostics

Striking a Balance between Risk and Value

Borne of the careful balance between innovation and regulation, quality medical devices diagnostics indeed improve the lives of patients. However, quality cannot be tested into the devices. 

Instead, it’s up to developers to keep tabs on current quality systems and GxP requirements, and the earlier in the development process these ideals are met, the better the results are for manufacturers and, most importantly, patients. 

With proactive project management and design controls, we help you start, scale, and sustain your GxP manufacturing. By balancing project management and design controls, Azzur Group’s guidance helps you meet or beat aggressive plans to enter the market, no matter the class, risk profile, or compliance challenge.

Start. Scale. Sustain.  

With proactive project management and design controls, we help you start, scale, and sustain your GxP manufacturing. By balancing project management and design controls, Azzur Group's guidance helps you meet or beat aggressive plans to enter the market, no matter the class, risk profile, or compliance challenge. 


Backed by a nationwide network of consulting, validation, lab, and IT compliance experts, Azzur Group is able to provide a holistic solution to the industry's most demanding challenges and regulatory demands.

  • 21 CFR Part 820 
  • ISO13485 
  • ISO14971 
  • Medical Device Regulations 
  • Part 11 Compliance 
  • Other FDA and International Regulatory Bodies
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