Synopsys Simpleware Receives MDR Certification

Posted on 2 April 2024 by Jessica James


We are delighted to announce that the Simpleware Product Group at Synopsys has received certification under Regulation (EU) 2017/745 (MDR). The certification builds upon our existing CE marking under Medical Devices Directive (MDD) and means that we are recognized as meeting the latest required standards for EU medical device safety and effectiveness, bringing our quality management system to a new level.

Synopsys Simpleware Receives MDR Certification

What is the MDR and Why Is It Important?

The Medical Device Regulation (MDR) is a European Union 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. To this end, we are proud of the dedicated work put in by the Simpleware Product Group to acquire MDR certification.

How Does MDR Certification Benefit Simpleware 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are following de facto industry requirements for medical devices, reducing the risks associated with non-compliant or outdated products that might translate to adverse events and reputational damage.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."

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Any Questions?

If you have any questions about the MDR certificate or our medical device clearances in general, please contact us.