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 … More...
Medical Device Consulting to Streamline Compliance and overcome regulatory challenges.
Quality System Development
Gap Analysis
Whether you need a gap analysis performed on your internal SOP’s for compliance to ISO 13485 or ISO 9001, Gap analysis to meet FDA 21 CFR … More...
Risk Management
Risk management in accordance with ISO 14971 is critical for any medical device. It is important for the company to have a … More...
Our Mission:
Providing experience, exceptional insight and understanding to start-up and mid-sized companies seeking to achieve the necessary quality and regulatory compliance in order to design, manufacture or sell an FDA-approved product.
CAPA Assistance
Qualitas can help you establish a CAPA system or can assist you in maintaining an already established system. Qualitas can assist with … More...
Contract Auditors
Qualitas can help with your compliance auditing needs. We have ASQ, Certified Quality Lead Auditors that can conduct audits for compliance … More...
Safety Testing
Medical devices are required to show they perform safely and effectively. Depending on the type and classification of device, certified … More...