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Insite QA provides consulting services to the bio-pharmaceutical/medical device industries. Insite QA has proven abilities in the development of Quality Management Systems, GXP regulatory compliance inspections and medical writing. We are committed to delivering products and services that ensure quality development outcomes to shorten time to market for new medical therapies.

When confusing regulatory requirements impedes getting your medical device to market and compliance to quality system regulations baffle you, then a consultant may be your answer. You can save time and money by supplementing your staff's time and your organization's expertise and avoid costly mistakes with our professional knowledge and network. 雇用正确的专业人才，可以节约时间和成本来解决质量和法规管理给企业所带来的问题。 迈特医疗器械咨询有限公司提供专业知识和人员来解决问题，帮助企业发展专业能力，快速将产品推向国际市场并成长为国际化公司。 医疗器械CE标记, 加拿大医疗器械符合性评价体系, 加拿大健康局CMDCAS认证, 美国FDA检查, 美国FDA 510 (k)程序, ISO 13485的体系注册, ISO 14971 风险管理, 医疗器械和医疗设备公司, MDD医疗器械指令, 有源植入医疗器械指令, 体外诊断医疗器械指令, 日本药事法, 澳大利亚治疗用品管理条例, 供应商和承包商审计 NOTICE: MedTech Review, LLC is a 2-member Minnesota Limited Liability Company, founded by John Beasley, RAC (US). Mr. Beasley does all consulting, and when necessary, specialized services are provided through his network of Associates. MedTech Review, LLC currently does not have employees.