Isli Consulting Logo - medical devices

Isli Consulting

medical devices
China's Best One-Stop Medical Equipment Provider
About

Isli Consulting specializes in regulatory affairs and quality assurance of medical devices and serves manufacturers globally. We take pride in our ability to deliver innovative and cost-effective solutions to your compliance challenges. Leverage our expertise and experience to achieve your regulatory and quality goals. [Regulatory Strategy] When you plan for launching your medical device in the US, Europe or Canada, Isli can provide the strategy that maximizes time and cost savings, minimizes regulatory burden and meets your business needs. [Regulatory Submissions] Isli takes a strategic approach to curate your 510(k) submission dossier and CE Technical Files. Each submission is built from the ground up with the characteristics of your product in mind to best demonstrate safety, performance and compliance to reviewers. [Quality Systems] Whether you are a manufacturer, initial importer or OEM, Isli can help you create a compliant quality system that prioritizes efficiency and ease of use.

Technologies
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Keywords
medical device quality assurance medical device regulation quality system risk management ce marking fda quality management system samd regulatory strategy iso 14971 iso 13485 compliance product development regulatory affairs design control 510 medical equipment manufacturing hospital & health care medical devices
Company Information
  • Employees 1
  • Founded 2020
Location

Calgary, Alberta, Canada

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