Multilateral Business Development

Medical Device Consulting & FDA/ISO Regulatory Affairs FDA 510K Notifications (Class II Medical Devices) FDA PMA Premarket Approvals (Class III Medical Devices) and NDA New Drug Applications • PMA Premarket Approvals for Class III Medical Devices • PMA Supplements and PMA Amendments •IDE Investigational Device Exemptions Quality Systems Implementation, ISO Certification, GMP, EU MDD and CE Marking • ISO 13485, ISO 9001, ISO 13488:2000 • ISO Quality Systems Implementation, Certification and Registration Consulting • CE Marking and EU Medical Device Directives Compliance (MDD, IVDD, AIMDD) •Audit preparation, documentation, QMS training… Dietary Supplements, Alternative Medicine FDA Approvals in US Laboratory Compliance Testing, Animal and Human Clinical Trials Risk Management • FDA Risk Management Guidelines • ISO 14971 International Regulations, Approvals and Permits • Import/Export Permits • US Medical Products Asian and EU Approvals • Europe/Asia Product FDA approvals for US Market • Global Distribution (Canada, Germany, UK, France, China, Japan, India …) • International Regulation Consultants Outsourcing/Off-shoring: Providing service excellence by identifying key client business issues, determining client needs by supplementing the standard assessment techniques and tools with innovative approaches, evaluating and validating analysis and developing recommendations for the client in the context of the overall engagement.

• Employees 8
• Founded 2010