About Pulse Axis Medical Device Consulting
Pulse Axis Medical Device Consulting is a leading firm dedicated to helping companies bring safe, compliant, and innovative medical devices to the U.S. market. We partner with innovators, startups, specification developers, and established manufacturers seeking expert guidance on U.S. regulatory requirements and quality system compliance.
We work with U.S.-based companies as well as foreign manufacturers entering the U.S. market, helping them understand and navigate FDA expectations and regulatory pathways, including presubmissions and 510(k) premarket submissions, De Novo classification requests, breakthrough designation requests, QMS implementation, human factors, and risk management documentation.
Our approach centers on cross-functional collaboration, ensuring teams stay aligned and submissions are accurate, complete, and strategically prepared. By leveraging internal efficiencies and optimizing documentation workflows, we help accelerate regulatory timelines wherever possible.
We support a wide range of medical technologies, including:
- In Vitro Diagnostics (IVDs)
- Software based medical devices (SiMD and SaMD)
- Medical imaging and radiological devices
- Traditional Class I and Class II medical devices
Pulse Axis Medical Device Consulting delivers strategic, clear, and actionable regulatory guidance that empowers companies to confidently navigate U.S. market entry and ongoing compliance.
