mdi Consultants Inc.

mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. mdi Consultants, Inc., is a Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent. Since 1978 mdiConsultants have been providing clients high-quality and high-value consulting services such as: FDA Compliance: regulatory strategy development, clinical trial development/ management, cGMP compliance, on site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services 510(k) submission assistance Services FDA Trouble Shooting Services 483 & Warning Letter Responses Services Quality System Compliance Services CE Mark Consulting ISO compliance – ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems, ISO Consulting Regulatory Consulting U.S. Agent Services Authorized Agent Services Import Agent Services European compliance – CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD) Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration Health Canada compliance – medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars

网站

https://www.mdiconsultants.com

mdi Consultants Inc.的外部链接

所属行业

法律服务

规模

11-50 人

类型

私人持股

创立

1978