Design Controls 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 812.30, Design Controls.

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 Design Controls system that is compliant with 21 CFR 812.30. This can be a partial or total system, depending on the specific need.