Medical Device QMS Consulting
Maximize Quality.
Minimize Burden.
Establish
At EnGenius, we create QMS procedures tailored to your business and product(s) such that quality and compliance are achieved in the least burdensome manner.
Improve
Every QMS needs to adjust to the evolving business needs and product revisions. Otherwise, it is only a matter of time before it proves suboptimal. EnGenius can help your business review and optimize existing QMS procedures in order to improve quality, streamline processes, and lower overall costs.
Support
The work of QMS never stops. Whether you have an unanticipated staff shortage due to employee turnover or are experiencing a temporary increase in workload, EnGenius can support meeting your existing QMS requirements.
Audit
Compliance is a cornerstone of every functional QMS such that regular internal audits are management system requirements. Whether you need a formal internal audit or just prefer to have an assessment of your system’s compliance risks, EnGenius can help with the applicable regulations and standards including:
ISO 13485:2016
ISO 14971:2019
ISO 62366-1:2015
ISO 62304:2006+A1:2015
ISO 82304-1:2016
ISO 14155:2020
FDA 21 CFR 820
FDA 21 CFR Part 11
EU MDR 2017/45
Contact Us
Whether you need support for the daily tasks or want us to revolutionize your QMS, it all starts with the first contact. Drop us a line!
ashkon@engeniussolutions.com
(657) 200-1550
555 Anton Blvd, STE 150
Costa Mesa, CA, 92626