Quality System Design and Implementation

Start-up companies have a long list of tasks to complete in order to release a medical device to market. Staying in compliance with medical device regulations is chief among them, and in the United States this involves complying with 21 CFR 820, the Quality Management System Regulation (QMSR) for the United States and the EU Medical Device Regulation (MDR) for Europe.

Setting up a compliant system within a company can take away from the focus of the engineers and technical inventors on their work. Bringing in help with this task is a welcome lifting of the burden.

Spiral Medical Development can help a start-up write and implement its own QMSR that is compliant with 21 CFR 820 and the MDR. This can be a partial or total system, depending on the specific need.

Possibilities include:

Gap analysis of a Quality Management System (QMS) to detect and categorize compliance issues
Drafting a new FDA/MDR compliant QMS for a startup
Focusing on remediation of a single QMS sub-system, e.g. Risk, Design Controls, Clinical Evaluation
Creation of one or several procedures within a company QMS
Responding to QMS audit findings from ISO, FDA, a Notified Body, or other regulatory bodies