Ansys Simpleware Medical Receives MDR Certification

We are delighted to announce that Ansys Simpleware Medical 3D image processing software has been certified under the European Unions (EU) Medical Device Regulation (MDR) 2017/745. The certification builds upon the existing CE marking under the Medical Devices Directive (MDD) and means that it is recognized as meeting the latest required standards for EU medical device safety and effectiveness, bringing our quality management system to a new level.

What is the MDR and Why Is It Important?

The MDR is an EU regulation that took effect on May 26, 2021, replacing previous MDD legislation with a more expansive set of requirements for safety, performance, and quality. Notable to this update to the regulatory framework is a greater emphasis on design traceability, labeling, clinical evaluation, and post-market surveillance, with the goal of protecting public health while fostering innovation within the medical device industry.

How Does MDR Compliance Work?

To meet MDR’s requirements, the entire medical device industry has been working closely with notified bodies to improve compliance and carry out comprehensive audits of quality systems. This process has been a major challenge for the industry due to the greater overall complexity of MDR compared to MDD, and MDR certification is still a relatively rare achievement.

How Does MDR Certification Benefit Simpleware Medical Software Customers?

By choosing an MDR-certified software company, our customers can trust that we are following de facto industry requirements for medical devices, reducing the risks associated with non-compliant or outdated products that might translate to adverse events and reputational damage. Compliance is not a one-time event for our team and software; it requires ongoing interactions with regulatory bodies to ensure continued product excellence and adherence to regulations.

Ronald Gull, Executive Director for R&D Engineering at Synopsys, has described the importance of the certification.

 "With growing regulatory requirements, medical device manufacturers face more stringent guidelines when it comes to selecting third-party vendors for their technology needs. By working with a provider that has achieved MDR certification, our customers can simplify the vendor selection process and expedite project timelines."

Learn more about Ansys Simpleware Medical software.