essential guide eu mdr compliance

The Essential Guide to EU IVDR Compliance

Expert guide overview

On May 25, 2017, the European Commission published the IVDR 2017/746, which introduced an expansive set of new rules for how in vitro diagnostic devices are regulated in the European Union (EU). New devices must be certified, and existing devices recertified under the new IVDR. This will require manufacturers to revisit their quality management system (QMS) and update core processes to ensure compliance.

You will learn:

Important dates for the IVDR transition
The IVDR requirements that will have the greatest impact on your quality management processes and product portfolio
Key steps for a successful IVDR implementation
How an enterprise quality management system (eQMS) can help simplify compliance

What we do

New product development (NPD) and new product introduction (NPI) practices have shifted over the last decade as companies have picked up the pace of innovation. Developing products with more electronics, software, and sensors requires keeping internal teams and external supply chains on the same page throughout the entire product lifecycle. Read this white paper to learn how to overcome barriers to product innovation and streamline your product development and launch processes.

How we deliver value

Competition is increasing at light-speed and products are becoming more complex as they connect devices, people, and systems. This requires solutions scale with your requirements. Arena PLM eliminates communication barriers, recuces costs, and increases profitability so you can deliver high-quality products to market fast.

Trusted by Over

1,300 Global Customers

"We get terrific feedback from the give and take of the review process. Indeed, partners have provided feedback that helped us avoid making unnecessary, confusing, or costly changes."

David Sangster | Senior VP of Operations, Nutanix