“I’ve engaged Grace to work on multiple projects over many years in areas as varied as AI in mammography, Workflow Automation in Diagnostics, Clinical Informatics and PACS in four companies. She is an essential resource for me when I need thoughtful and knowledgeable insights. I have worked with her both as a “part-time VP Q&RA” in a start-up as well as providing an second expert opinion in large companies going through transformations related to agile software development, software-as-a-medical-device, and adaptations of regulations to the fast moving field of digital health. Grace does not only bring the expertise, but also a collaborative and inclusive approach, bringing the whole team on board with facts and references. When the next intractable regulatory puzzle steps in my way, I will call Grace again.”

— Wido Mendhart, Ph.D.  |   Executive Vice-President Digital Health   |  Siemens Healthineers

“I have worked with Grace for many years and immediately brought her into help when we were starting APN Health. Over the past 7 years, Decus has helped us with our Quality System, document control, design documentation, regulatory submissions, audits, and clinical studies. Our team enjoys working with them and they provide valuable support to all our efforts.”

— David Geddam | Chief Technical Officer | APN Health

“I greatly appreciated Decus’s work in getting my novel anesthesiology catheter cleared by FDA. They helped with the design documentation as well as the regulatory submission. During a difficult FDA clearance process, they were persistent in addressing issues and consistently came up with good solutions to problems. They were willing to do whatever was necessary to help me be successful.”

— Chunyuan Qiu, MD | Chief Executive Officer | Ancora Medical Technologies

Decus was incredibly helpful to our start-up as we developed a regulatory strategy and prepared a pre-submission request for FDA. Not only were they a pleasure to work with but they came up to speed very quickly and did great quality work. We couldn’t have been happier with our collaboration and look forward to working with them again in the future.”

— Lori Arakaki, Ph.D. | Chief Executive Officer & President | Opticyte, Inc.

“We’ve had a great experience working with Decus for over a year as we have developed new tools to deliver cognitive behavioral therapy. The Decus team has helped us across a broad range of activities: implementing the CQO Quality System, considering regulatory options, discussing issues with FDA, developing our design documentation, and starting clinical studies. They not only deliver excellent work but have been incredibly dependable and always ensure we meet our timelines.”

— Stephen Dunne | Chief Digital Therapeutics Officer | Koa Health

“The Digital Pathology regulatory path is very innovative and as such the regulatory pathway has had to be uncovered and paved. Grace and the Decus team are very capable, knowledgeable and very efficient in helping us in this trajectory. They are very engaged and give thoughtful insights. They deliver consistent, excellent quality work ontime or even earlier. I find the team very flexible and great to work with. That is why I have been working with them for over 8 years now and can recommend them to anyone.”

— Esther Abels | Chief Clinical and Regulatory Officer | VisioPharm

“I’ve known and worked with Grace for a number of years and have referred Decus to a many new companies that are at the stage where they need a Quality System. I’ve seen many Quality Systems and appreciate how Decus’s CQO offering is an excellent solution for start-ups that need to implement a fully functioning Quality System in stages – with the ability to grow by increments as they move from initial product development, to manufacturing to post-marketing management. CQO reflects Decus’s extensive knowledge of the regulations and standards, and provides the tools in an easy to use format that ensures understanding and compliance.”

— Rob Newman | Principal | Scion Consulting