Navigating Regulatory Compliance in the EU Market

CE Marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).

A Quality Management System (QMS) is a set of processes, procedures, and policies that ensures the consistent quality of a medical device throughout its lifecycle. Auditing is an important part of the QMS, as it helps to identify areas of improvement in the system...

Labeling is the display of any information about a product on its label and is a part of branding, which helps in product identification. It is a typically printed information that is bonded to the product for easy recognition, and contains specific information such...

MDR Compliance is a service designed to help medical device manufacturers comply with the requirements set forth by the European Union's Medical Device Regulation (MDR). This service involves a comprehensive evaluation of the manufacturer's products to determine if they meet the new requirements set...

Regulatory Strategy: It is a set of policies, procedures, plan or actions that help a business bring a product to market by identifying and addressing the legal, compliance, and risk management needs. It involves strategic planning to take the products approved in one region to...

A Marketing Authorization Holder (MAH) is the entity responsible for obtaining and maintaining regulatory approval of CE Marking for a medical device or IVD in the EU. Marketing Authorization is the person or company who is licensed to distribute, sell and commercialize a medical product....