China's Best One-Stop Medical Equipment Provider
About

Prime Path Medtech™ is a medical device consulting company based in Minnesota, with an additional office in Salt Lake City, Utah. Founded in 2017, the company specializes in providing comprehensive services across product development, regulatory affairs, quality assurance, and clinical research. They primarily partner with small and mid-sized medical device companies, assisting them throughout the product lifecycle to achieve strategic regulatory planning and successful market entry. Their core services include regulatory consulting, clinical research organization (CRO) services, quality auditing, and product development support. Prime Path Medtech operates a "shared services" model, offering clients access to a wide range of expertise at a lower cost than maintaining full-time in-house resources. The team consists of highly qualified biomedical engineers and project managers, ensuring expert guidance in navigating regulatory complexities and accelerating product development. The company emphasizes a client partnership approach, focusing on customized solutions and reliable support.

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Keywords
servicescost reduction strategiesde novo pathway supportregulatory compliance solutionsclinical evaluation supportclinical trial managementclinical research cro servicesclinical evaluationsiso 13485quality system implementationregulatory audit preparationb2bmedical device prototypingfractional staffingmedical devicesmanufacturingmedical device standardscost-effective solutionsmedical device engineering supportglobal regulatory supportfda 510k and pmahealthcarefda 510kregulatory submission supportfda submissionsdevice development lifecycleproduct development consultingmedical device quality systemcost-effective prototypingregulatory consulting services
Company Information
  • Employees12
  • Founded2017
Location

Minneapolis, Minnesota, United States

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