The new Medical Devices Regulation (EU) 2017/745, and the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. The Medical Devices Regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three existing Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices.
The complete transition from MDD to MDR—from gap assessment through post-market surveillance, technical documentation including Design History File (DHF), and Risk Management File (RMF) preparation.
Qualified team of experts with hands-on experience across all categories of Medical Devices.
Expert support for region-specific Regulatory complexities
Interactions with Health Authorities (HAs)
Structured approach to ensure quick product launch or market access
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.