WEST CHESTER, PA — Archimedic has unveiled OpenQMS, a free, web-based platform designed to help medtech companies efficiently manage Quality Management processes throughout the medical device development lifecycle. The platform aims to bridge the gap between regulatory requirements and the resources available to emerging medtech companies.
“The unfortunate truth is that many medtech companies don’t have the expertise required to implement and maintain their own Quality Management System,” said Eric Sugalski, Archimedic’s founder and Chief Technical Officer. “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 provides access to a comprehensive suite of resources, including 24 downloadable forms and templates that address key aspects of quality management, such as Failure Modes and Effects Analysis (FMEA), User Needs, and Hazard Analysis (HA). Each form includes detailed tutorials, step-by-step instructions, and examples to guide users through the documentation process necessary for regulatory compliance.
The initiative addresses one of the most pressing challenges faced by medtech developers—limited financial and technical resources for maintaining a rigorous quality program. “Medtech development is a financially burdensome activity, and maintaining a rigorous Quality program is often beyond the financial resources of many medtech companies,” said 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 OpenQMS is designed to offer a self-service solution, Archimedic also provides additional support for companies requiring assistance in implementing comprehensive Quality Management Systems. As an ISO-13485 registered company, Archimedic is positioned to provide expert guidance to medtech companies navigating complex regulatory landscapes.
OpenQMS represents a significant step forward in reducing barriers to entry for medtech firms, empowering them to meet industry standards while focusing on innovation and development.
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