Borne of the careful balance between innovation and regulation, quality medical devices 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 cGMP requirements, and the earlier in the development process these ideals are met, the better the results are for manufacturers and, most importantly, patients. Without proactive project management and design controls, transitioning from R&D to GMP manufacturing can stall even the most aggressive product launches. That’s where Azzur Group comes in.
Example of a Medical Device design and development cycle
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
- Medical Device Regulations
- Part 11 Compliance
- Other FDA and International Regulatory Bodies
Our Medical Device Consulting Services
By balancing project management and design controls, we help partners meet or beat their agressive plans to enter the market, no matter the class, risk profile, or compliance challenge.