Medical Device Academy

Medical Device Academy is a private U.S.-based medical device quality and regulatory consulting firm focused on helping MedTech companies, especially startups and small device manufacturers, bring products to market and maintain compliance. The company provides FDA 510(k), De Novo, and pre-submission consulting, as well as support for ISO 13485, MDSAP, CE marking preparation, Canadian license applications, human factors, and quality system auditing. It also sells training products including webinars, courses, templates, and a turnkey quality management system. The business is service-driven rather than therapeutics-driven, with emphasis on regulatory affairs education and practical implementation support for medical device companies. The company operates as a remote team and appears to be actively offering consulting and training services in 2026.