Medical Device Academy, Inc.

medical devices

About

Medical Device Academy, Inc. is a quality and regulatory consulting firm based in Shrewsbury, Vermont. The company specializes in assisting small medical device companies with regulatory compliance and market entry in the U.S., European, and Canadian markets. Operating virtually, the team consists of around eight to ten employees primarily located in the Eastern Time Zone of the U.S. The firm offers a range of services, including preparation and submission of FDA 510(k) notifications, quality management system implementation, and regulatory pathway analysis. They provide support for CE Marking and Canadian licensing, as well as training and education through courses and webinars. Their educational products include a comprehensive 510(k) course series and a specialized book on 510(k) preparation. Medical Device Academy focuses on helping startups and early-stage developers navigate complex regulatory pathways to bring their medical devices to market efficiently.

Technologies

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Keywords

510 submissions ce marking mockfda inspections continuing education for regulatory compliance canadian medical device licensing mdsap certification iso 134852016 de novo submissions software medical devices oem information technology medical health care medical equipment manufacturing regulatory consulting canadian license applications risk management fda pre-submission templates quality system audits fda pre-submission de novo classification fda 513(g) submissions regulatory strategy estar template medical device testing fda 510(k) book clinical testing support pre-market notification regulatory documentation

Location

345 Lincoln Hill Rd, Shrewsbury, Vermont, United States, 05738

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