Quality Management System (QMS)
Whether it lives in binders in a filing cabinet or in a fully-featured software, a quality management system is the backbone of a successful medical device company and ensures that the products you design and manufacture are safe and effective.
We offer a full set of procedures and templates available for purchase that are compliant to US and EU regulations as well as ISO 13485, ISO 14971, IEC 62366-1, and IEC 62304.
Here are a few of Cooperative Quality Solutions’s favorite quality management systems to implement for our clients.
Greenlight Guru is one of the fastest electronic quality management systems (eQMSs) to implement because the software is minimally configurable, was designed exclusively for the medical device industry, and comes pre-validated. It works best for small-medium sized companies who are flexible on how their QMS works.
Qualio is one of the market leaders in electronic quality management systems (eQMSs) for life science companies due to its ability to be configured to meet your needs. It works best for small-medium sized companies who have an established QMS and know what they want out of a QMS.
Paper-based quality management systems are the most cost effective to implement since they do not require any eQMS software. They work best for companies with a small number of employees who are all co-located.
Contact us to learn more about these and other QMS options for your medical device company.