Navigating Regulatory Compliance in the EU Market

Unlocking Opportunities and Ensuring Compliance for Medical Devices and IVDs in the European Union Region

MEDICAL-DEVICE

Medical Device

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    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).

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    Quality 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...

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    Labeling 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...

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    MDR 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...

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    EU 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...

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    Marketing 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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