Medical device manufacturers in Europe or outside Europe, who wish to sell their devices in the EU have to undergo conformity assessments. This is to ensure that the devices are safe and perform as per their intended use. The EU Member States can designate authorized notified bodies to conduct conformity assessments.
The conformity assessment process typically involves an audit of the quality system of the manufacturer and a review of technical documentation from the manufacturer regarding the safety and performance of the device.
Maven helps you through this process by guiding you in documentation preparation, reviewing them and carrying out mock audits. We are also present during the audits, to ensure smooth functioning and help the manufacturer pass the conformity assessment. Once the device passes the conformity assessment, the manufacturer can place the CE mark on the medical device.
Services We Provide
CE for Medical Device
Legally place your medical devices in Europe by complying with the General Safety & Performance Requirements laid down by the relevant European Medical Device Regulations.
CE for In-Vitro Diagnostic Device (IVD)
From assisting you in preparation and compilation of technical file to application and procuring CE mark of conformity for your In-Vitro Diagnostic (IVD) device by complying with the applicable In-Vitro Diagnostic Regulations.
Clinical Evaluation
Demonstrating the safety and efficacy of your Medical and In-Vitro Diagnostic Medical devices via scientifically sound methods that continuously collect, analyze and evaluate the clinical data related to the device.
Post-Market Surveillance (PMS)
Post-market surveillance (PMS) is a system that gives continuous feedback about the performance of devices on the market in order to maintain a high standard of product quality.
CE for Medical Device Software (SaMD)
The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being a part of a hardware medical device."
CE for PPE
Personal protective equipment enables user protection against hazards at work, at home or at leisure. There are mechanisms in the professional setting to achieve what the Union sees as an essential right that of health and safety at work.
Gap Analysis
A Gap Analysis is a strategic planning tool to help you understand where you are, where you want to be and how you’re going to get there
European Authorized Representative (EAR)
European Authorized Representative will act on the manufacturer's behalf with respect to specified tasks and will have to keep this liaison as long as you want to sell your products in Europe.
Unique Device Identification (UDI)
The UDI system will promote easier traceability of devices and will considerably advance the post- market surveillance activities and allow better regulation of medical devices by the competent authorities.
EUDAMED Registration
EUDAMED database is the IT system engineered by European Commission to put into effect Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic devices.
Liability Insurance
With the enforcement of the Regulation (EU) 2017/745 and 2017/746 for medical device and In-vitro Diagnostic Devices, it is obligatory for manufacturer of device to take Product Liability Insurance with ample coverage or arrange equivalent financial guarantee.
MD QMS (EN ISO 13485)
MDQMS is systematic procedure and process covering all the aspects of design, manufacture, distribution. ISO 13485, is the most widely used standard for MDQMS issued by International ISO.
