We can provide Quality Management System support for:
- ISO 13485:2016 certification
- FDA 21 CFR Part 820
- EU MDR 2017/745
- ISO 9001:2015
We can help with a turnkey, custom quality management system to meet regulatory and quality compliance or help you modify your current quality management system.
Qualitas can help!
We will conduct a gap analysis of your current system, isolate the weaknesses and help you determine cost-effective solutions to fit your company. We work with your team every step of the way and once your QMS is complete, Qualitas can provide training on the new process areas.
Once the Quality Management System is established, we can assist with walking your team through ISO 13485 Certification.
From initial contact with the registrar to providing representation during the Stage 1 and Stage 2 certification assessment, Qualitas can help you with every step along the way!
Helpful Links: FDA and Medical Device Industry