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.
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 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.
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.
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.
Meet all the regulatory requirements in advance.Contact Us