CREDIT: AdobeStock_529829862
Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, web-based platform for helping companies navigate the Quality Management process throughout the medical device development life cycle.
“The unfortunate truth is that many medtech companies don’t have the expertise required to implement and maintain their own Quality Management System,” says Eric Sugalski, Archimedic’s founder and CTO. “However, this doesn’t change the fact that a robust Quality program is required for authorization by regulatory agencies such as the FDA. OpenQMS aims to close this gap between the capabilities of medtech companies and the requirements of regulatory bodies.”
OpenQMS is a free resource provided by Archimedic to offer downloadable forms and templates commonly used during the medical device design and development process. In addition, video tutorials are provided illustrating how to fill out and maintain each of these forms. Step by step instructions and examples are also provided in each of the forms. Example forms include Failure Modes and Effects Analysis (FMEA), User Needs, and Hazard Analysis (HA). In all, 24 separate forms are provided, covering the bulk of QMS needs for most medtech firms. These resources are provided at no cost to give device developers a jump start on the rigorous documentation process associated with medical device development.
“Medtech development is a financially burdensome activity, and maintaining a rigorous Quality program is often beyond the financial resources of many medtech companies,” says M. Alexander Shaw, CEO of Archimedic. “We want to even the playing field by providing a low-cost path to Quality compliance for medtech companies. We feel OpenQMS accomplishes that goal.”
While the intent of OpenQMS is to provide low-cost access to Quality compliance, Archimedic recognizes that there may be times that clients will require additional assistance in implementing their Quality program. As an ISO-13485 registered company, Archimedic is fully qualified and capable of providing support to these companies.