AME Quality & Compliance Solutions, LLC.
We Provide Quality and Regulatory Solutions
X Cath, Inc.
"We just passed our ISO 13485 certification audit and the auditor was very please with the quality of procedures and well developed QMS."
MANSCAPED
"AME led Confirm Biosciences in establishing the entire Quality Management System, delivering us from ill-defined procedures and record-keeping to being one of the most stringent standards."
Confirm BioSciences
"It was a privilege to work with Arlyn, and I am happy to give her my sincerest endorsement. I would happily recommend her to any organization seeking to improve their quality systems!"
AME developed a full quality management system for us. This entire process has been very quick and efficient. We just passed our ISO 13485 certification audit and the auditor was very pleased with the quality of procedures and well developed QMS. It's been pleasure to work with Arlyn and we continue to use her services.
- Viljar Palmre, VP of Electro-Polymer Research and Development at XCath, Inc.
AME led Confirm Biosciences in establishing the entire Quality Management System, delivering us from ill-defined procedures and record-keeping to being certified to one of the most stringent standards, ISO 13485:2016 for medical devices. It was great working with Arlyn and I highly recommend her and her team for any Quality Management solution needed.
- Joshua Giberson, Project Manager - Hard Goods at MANSCAPED
I had the distinct pleasure of working with Arlyn to establish our QMS while I was with Confirm Biosciences. In that time, not only was she responsible for helping to develop CB’s quality strategy and implement a custom QMS, but she successfully led the effort to attain ISO 13485:2016 certification!
This achievement was possible thanks to her deep understanding of FDA QSR, ISO 13485, and EUMDR in addition to her ability to quickly embed within our organization and help translate our existing processes.
It was a privilege to work with Arlyn, and I am happy to give her my sincerest endorsement. I would happily recommend her to any organization seeking to improve their quality systems!
- Javier Castillo, Director, Marketing Operations at Confirm BioSciences