“The Agilis team members use their experience and expertise to provide clear and candid input, which they deliver in a collegial and professional manner. Their integrity is absolutely impeccable and their insight is superb. We have learned a lot through working with Agilis and would recommend them to anyone needing human factors testing.”
— Jana Napolitano, Vice President and Head, Regulatory Affairs Strategy, Bayer U.S.
 

Happy Clients

 

“I want to take this opportunity to thank Agilis for the excellent work that has been carried out. In particular your ability to adapt to our ever changing and demanding timelines has been impressive. Integrity is also something that comes to mind straight away when I think of Agilis…You also ensured that the approaches taken were as cost effective as possible for AZ. The technical knowledge and experience provided by Agilis has been vital to this project…Above all working with Agilis has been an enjoyable experience...Through-out the time we have worked with Agilis it was apparent that your reputation is very important to you and we can see why, its been well earned and maintained.”

— James Meehan, Senior Device Quality Engineer, AstraZeneca

“I had worked with Pat in the past, so when we needed expert advice on human factors testing with a medical device and labeling which laypeople could understand I called her in a heartbeat. The team at Agilis Consulting Group was invaluable in their assistance as we navigated through the new waters of Regulatory Change as it pertained to home-use infusion pumps. Their intimate knowledge of Assurance Case Reporting and excellent human factors knowledge was pivotal to our submission and subsequent clearance. Pat and her team are responsive, professional, and timely. They are passionate about the end user’s experience and safety. I strongly recommend Pat and her team, they are one of a kind in this evolving and growing space.”

— Linda Parks, National Director, Clinical Education, Tandem Diabetes Care

“Agilis Consulting Group developed and delivered on a plan that delivered excellent Human Factors data and allowed us to gain FDA clearance for our Class II medical injector device. Their team was professional, extremely competent and delivered on a tight schedule with very specific parameters. Not only does Agilis have the technical knowledge and expertise, but their people are great to work with and are hard workers. It's great to see a company deliver on its promise and all within budget and deadline!”

— Caleb Hernandez DO, FACEP, Chief Medical Officer, CertaDose Inc.

“Agilis Consulting Group was instrumental in helping our company develop and execute a successful human factors testing program that supports the safety claims for our product. They developed and executed the testing program that not only passed FDA scrutiny, but was on-time and under budget! Pat was a delight to work with and helped ensure that our needs were met during the entire process. I would highly recommend Agilis to anyone who needs expert human factors testing and labeling development for their medical product.”

— Jill Schweiger, former Vice President Clinical Studies & Regulatory Affairs, Flowonix Medical, Inc.

Our Additional Satisfied Clients

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