Our process
AX1 Medical supports original equipment manufacturers (OEMs) and companies throughout the entire process of bringing medical devices to market, from concept to market readiness. First, we ask about the intended use of the medical device. In addition, we assess safety, efficacy and regulatory compliance.
Consultation
With a deep understanding of the intended use of the medical device, we assess its safety, effectiveness, and compliance with regulations.
Planning
Creating a comprehensive strategy for obtaining certification, such as identifying applicable standards and regulations, defining the certification scope, establishing timelines and milestones, assigning responsibilities, and allocating resources efficiently.
Documentation
All our services come with detailed documentation to ensure a seamless and high-quality process.
Execution
The execution phase involves implementing the planned activities of testing, audits, clinical evaluation, and potentially preparing the certification submission.