SMARTCHECK MDR

SMARTCHECK MDR is a highly effective tool that PharmaLex developed to assist medical device manufacturers in assessing the MDR readiness of their medical devices and quality management systems. It was developed based on our deep understanding of both the greater complexities companies now face under the MDR and the many different types of products affected by the new requirements — from traditional devices to new technologies, to software-as-a-medical-device solutions such as mobile phone apps. Let PharmaLex’ SMARTCHECK MDR tool handle these new and complex compliance needs on your behalf so that you can be assured your devices will get to — and stay on — the European market.

SMARTCHECK MDR is a unique tool that helps our clients learn their compliance status and the steps necessary to ensure full compliance. It does so by providing evidence both efficiently and cost effectively — for example, by offering insights into MDR readiness — and it frees you to focus on your business and on developing your medical device while we attend to full regulatory review. All you need to do is answer the questions, and the tool will provide a roadmap of the required steps.

One of our team of experienced medical device consultants will be available to answer questions during the implementation of SMARTCHECK MDR. Once implemented, a half-day workshop will be held to discuss the findings and identify the most appropriate way forward to work towards full MDR compliance from both a regulatory and quality viewpoint. The outcomes from the workshop will be documented in a comprehensive report to support you through the launch and maintenance of your devices on the European market.