The New Medical Devices Regulation (MDR): Insights and Perspective from a Notified Body

We understand that it is essential to have confidence in your Notified Body partner. Confidence in a partner that adds value to your business leads to an efficient, effective and robust CE Marking process. ECM focuses on regular communication from the very beginning. We appoint a dedicated team whose goal is to deliver on time and offer a complete portfolio of solutions. We make it quite simple to transfer your CE Certificate to ECM.

The benefits of transferring  to ECM include:

Save time & money

ECM’s comprehensive “Concierge Service” assists you in transferring your product and system certification in the fastest and most cost effective manner.

Shorten Time to Market

Our flexible services accelerate market access for your medical devices. We provide you with tailored services that match your business needs.

Complete testing and assessment

ECM provides support during every phase of the certification of your medical device, from the initial application to market launch.

Enjoy the whole process

with ECM’s web based portal, you are able to monitor the status in real time, exchange information online, share documents, and more.

ECM’s Transfer Process

1. Contact ECM

Contact ECM to discuss your current situation and timeline for transferring. We will want to see your certificate and list of certified devices.

2. Receive Proposal

Based on this discussion We will provide a proposal for the transfer.

3. Timeline & Process

Upon order acceptance we will assigned a reviewer and provide a timeline of the full process through to issuing your new certificate. A team of experts will provide you with the highest quality certification process activity.