CE Certification Consultancy for Medical & IVD Devices

End-to-End Support for CE Certification & Conformity Assessment of Medical Devices

Medical device & In Vitro Diagnostic Device (IVD) manufacturers—whether based in Europe or outside—must comply with European regulation EU MDR 2017/745 and EU IVDR 2017/746 if they intend to market their Medical device & In Vitro Diagnostic Device (IVD) in the EU. A crucial part of this process is undergoing a conformity assessment, which verifies that the device is safe, effective, and performs as intended use and complies with European regulation EU MDR 2017/745 and EU IVDR 2017/746.

EU Member States authorize designated notified bodies to perform the conformity assessment process. The process typically includes a thorough review of technical documentation follow to the audit of the manufacturer’s quality management system.

As experienced EU MDR 2017/745 and EU IVDR 2017/746 consultants, Maven provides end-to-end EU MDR 2017/745 and EU IVDR 2017/746 consulting services to streamline your certification journey. We assist in preparing and reviewing technical documents like

Clinical evaluation for medical devices as per EU MDR 2017/745
GSPR
Post Market Surveillance documents
Performance study for In Vitro Diagnostic Device (IVD) as per EU IVDR 2017/746
Risk Management as per ISO 14971

Our expert guidance helps ensure a smooth process, enabling you to meet EU requirements and confidently affix the CE mark on your medical device & In Vitro Diagnostic Device (IVD).

Services We Provide for CE Certification Regulatory Consultancy

Regulatory consultant for CE Certification under EU MDR 2017/745 for Medical Devices

Our team of experts helps you get your medical devices certified by meeting the European Medical Device Regulation (EU MDR 2017/745) with the guidance of experienced EU MDR consultants, We ensure your devices meet all the safety and performance requirements as per EU MDR. We offer EU MDR consulting services to make the conformity assessment process simple and smooth, so you can legally place your medical devices in Europe.

CE Certification Consultants for In Vitro Diagnostic Devices (IVDs)

We help you with every step of getting CE certification for your In Vitro Diagnostic device (IVD). From preparing and organizing your technical file to ensuring your device meets the European Medical Device Regulation, we guide you through the whole process of performance, analytical specificity studies. Our EU IVDR consultants offer expert EU IVDR consulting services to help you achieve conformity assessment and comply with In Vitro Diagnostic device (IVD) regulations EU IVDR 2017/746.

Clinical Evaluation for Medical Devices

Clinical evaluation is the process of demonstrating that a medical device is safe and performs as intended. It involves collecting, analyzing, and assessing clinical data using scientific methods. This data is essential to show that the device meets the requirements of the European Medical Device Regulation (EU MDR). As EU MDR consultants, we play a crucial role in guiding medical device manufacturers through this process, ensuring that their clinical evaluation documentation complies with all relevant conformity assessment requirements under the EU MDR and MEDDEV 2.7/1 Revision 4.

Post Market Surveillance (PMS) for Medical Devices

Post Market Surveillance (PMS) helps track the performance of medical devices after they are on the market. It ensures the devices continue to meet quality standards and stay safe for use. Under European Medical Device Regulation (EU MDR), PMS is a key part of maintaining product safety. As regulatory consultants we guide manufacturers in setting up PMS systems, ensuring compliance with medical device & In Vitro Diagnostic (IVD) regulation in Europe. Regular monitoring and feedback help in the conformity assessment process, keeping devices safe and effective for patients.

European Authorized Representative (EAR)

An European Authorized Representative (EAR) acts on behalf of a manufacturer, helping with tasks required under the EU MDR 2017/745 and EU IVDR 2017/746 .. The EAR keeps track of regulatory requirements, handles communication with authorities, and assists in conformity assessment. If you want to sell your products in Europe, you need to have an EAR, and they’ll remain in this role as long as you're in the market.

CE Certification Consultancy for Software as Medical Device

Our EU MDR consulting services help SaMD manufacturers through the European Medical Device Regulation (EU MDR) to ensure compliance. Our regulatory consultants assist with all steps, including conformity assessment, making sure your software meets all necessary standards for market approval in Europe. We help you understand the European medical device regulation EU MDR 2017/745 and ensure your SaMD is compliant, safe, and ready for certification.

Multiple Devices, One Trusted Path to CE Certification

Expert CE Certification Support for Medical & IVD Devices

End-to-End Support for CE Certification & Conformity Assessment of Medical Devices

Services We Provide for CE Certification Regulatory Consultancy

Regulatory consultant for CE Certification under EU MDR 2017/745 for Medical Devices

CE Certification Consultants for In Vitro Diagnostic Devices (IVDs)

Clinical Evaluation for Medical Devices

Post Market Surveillance (PMS) for Medical Devices

European Authorized Representative (EAR)

CE Certification Consultancy for Software as Medical Device

Get CE Certified with Expert Help – Fast, Simple & Stress-Free!

CE CERTIFICATION CONSULTANCY FOR MEDICAL DEVICE

CDSCO APPROVALS FOR MEDICAL DEVICES

US FDA 510(k) APPROVAL CONSULTANCY

UKCA CERTIFICATION REGULATORY CONSULTANCY

OTHER REGULATORY CONSULTANCY