EU Market
Medical devices and IVDs in the EU region must undergo a conformity assessment to demonstrate compliance with legal requirements.
The European Medicines Agency (EMA) assess high-risk devices and provides opinions for specific cases. EMA’s involvement ensures patient safety and regulatory compliance.
Services in EU Market
CE Marking
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).
READ MOREQuality Management System (QMS) and Audits – ISO 13485 Standards
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...
READ MORELabeling and IFU Management
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...
READ MOREMDR and IVD Compliance
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...
READ MOREEU Regulatory Strategy and Consulting
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...
READ MOREMarketing Authorization Holder Services
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....
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