“We selected Hasnaa Fatehi out of a list of several consultants to help with a US FDA project. Hasnaa tackled our project with expertise, dedication and timeliness. Hasnaa has in-depth knowledge of Quality Management Systems and Regulatory requirements. She has experience working with small and medium-sized, medical device companies and a strong understanding of business pressures. She worked with our QA/Regulatory Affairs Manager, addressed the issue, documented it for future audits and set up processes to avoid similar situations from occurring again. She also spent a sizeable amount of time educating the team and building our in-house capability. This allowed us to smoothly run our QMS with minimal reliance on her support and successfully pass our annual surveillance audit. I strongly recommend Hasnaa Fatehi to any medical device company, seeking to place safe and effective devices on the market while balancing compliance and business needs."