European In Vitro Diagnostic Regulation (IVDR) is set to replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).
The first step is to determine if the product is a medical device as defined by the Directive. The In Vitro Device Directive Article 1, point 2b defines an IVD as any medical device eg:
Reagent, Reagent Product
Calibrator, Control Material
Kit
Instrument, Apparatus
Equipment, System
Expertise
Dedicated experts’ team to support post-market surveillance (PMS)
Gap Analysis of IVDR General Safety and Performance Requirements
Clinical Performance Reports based on literature
Post Market Performance Follow up (PMPF) protocols and Reports
Post Market Surveillance (PMSR) Protocols and Reports
Advantages of In Vitro Diagnostic Regulation (IVDR)
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.