Decus Biomedical now offers more than just consulting.
We’ve leveraged our extensive experience to offer new tools and services that will have immediate and positive benefits to your medical device company.
Decus Consulting
Since our start in 2004, Decus has helped over 150 different clients. Some projects have involved reviewing a few documents. Larger projects have included establishing a full Quality System, conducting a clinical trial, and writing a 510(k) or PMA. While 80% of our clients are start-ups, we also work with multi-national corporations. We are fast, efficient, and flexible.
CQO (Contract Quality Organization)
Decus CQO eases and expedites Quality System implementation, our team manages the details, while your team focuses on your product. Decus CQO is a turnkey Quality System appropriate for start-ups. Establishing a Quality System is a hassle for any start-up medical device company. Engineers end up spending time preparing and reviewing quality procedures, rather than focusing on product development. For a fixed fee, Decus CQO offers immediate access to the procedures, templates, and forms relevant to your phase in the product development process. We provide training, document control staffing, progress reporting, and a dedicated and validated electronic system to manage all your files and signatures. In the same way you’d contract your manufacturing or clinical research, you can outsource your Quality System and focus on your product.