Medical device software brings new complications around compliance
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SMARTCHECK MDR
Regulation (EU) 2017/745 (MDR) on medical devices became effective on May 26, 2021
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.
ARE YOU MDR READY
Take our survey consisting of five simple questions. Your answers will give you a taste of the ways our SMARTCHECK MDR tool will help you transition – and continue commercializing – your products. The results are delivered in an easy-to-view traffic light alongside a clear explanation.
DIGITAL HEALTH ASSESSMENT
Are you developing health-related software or smart apps? Do you know if your software or app will be classified as a medical device? Does your product meet the MDR requirements? Complete our short questionnaire
to find out what help you need.
Contact us to find out how PharmaLex can support your EUMDR readiness
Features
- Compliance: The SMARTCHECK MDR tool will complete a full MDR-readiness assessment of your product(s).
- Quick access to expertise: Concise, focused, and highly effective results will ensue after a half-day workshop at fixed cost.
- Objective assessment: The tool will give full transparency on where you stand and clarity on what steps to take next.
- Reporting: A comprehensive report will document everything you must do to achieve MDR compliance.
Benefits
- A unique, evidence-based, efficient, and cost-effective way to find out where you stand and what to do next.
- An effective litmus test and smartly chosen targeted measures to implement.
- A SMARTCHECK MDR-conducted assessment that lets you focus on your business and future product development.
- Peace of mind via a 360-degree assessment of risk in achieving compliance.
Find out more about our depth of expertise by watching a video in which PharmaLex medical device specialists Malcolm Pinfold and Kim Wharton discuss the key considerations and implications of the new medical device regulation and the things companies should attend to:
