Assess Your EU MDR Readiness
With the Smartcheck-MDR Compliance Tool
An Efficient and Cost-Effective Approach to Managing Full MDR Compliance
PharmaLex delivers the tools and regulatory expertise that medical device companies you need to confidently transition to the EU Medical Device Regulation (MDR).
Assess Readiness, Close Gaps
SMARTCHECK-MDR helps medical device manufacturers prepare for the more stringent requirements of the MDR with a robust tool that helps organizations:
- Ensure readiness based on key areas of impact
- Understand compliance status
- Evaluate regulatory risks
- Take the necessary steps to close gaps
Handle Regulatory Compliance with Confidence
An assessment and workflow tool, SMARTCHECK-MDR has been designed to help medical device manufacturers assess MRD readiness of their medical devices and quality management systems.
- Ensure regulatory compliance with new regulations in order to be able to sell medical devices in the European Union
- Get ready for the In-vitro Diagnostic Regulation – IVDR – a new set of regulations governing diagnostic medical devices
Access a Range of Solution Packages
With SMARTCHECK-MDR, you have access to full range of tailored solution packages designed to flexibly scale according to need.
- Assess readiness and get automated reports and a customized risk scorecard via the intuitive, self-guided tool
- Get access to medical device experts with comprehensive packages that can help you move from planning to a full implementation plan within the required timelines
Consider Us Your MDR Expert Resource
With SMARTCHECK-MDR We Keep You on Track.
We help you evaluate:
- Quality management systems
- Notified body management
- Post-market vigilance
- Technical files
- Clinical evidence
Considerations and Implications of the MDR
Led by Expertise, Powered by Knowledge of the MDR
Whether you’re a company transitioning from the Medical Device Directive to the MDR, a new entrant to the European market, or looking for an independent third-party assessment of your regulatory risk, SMARTCHECK-MDR is:
Designed to provide full transparency
With its robust reporting capabilities, the tool provides a comprehensive readiness summary, with an overall score and a list of targeted recommendations. The dashboard weighs complexity and regulatory risk to give your teams an action plan on immediate focus areas.
Flexible enough to scale with need
From an automated 360º readiness report, to a consultant-led engagement that includes an in-depth assessment, risk heat map, and strategy, to a more in-depth gap assessment and implementation plan, PharmaLex tailors its MDR solutions to meet your needs.
Supported by leading MDR expertise
If needs extend beyond the assessment, PharmaLex delivers concise, focused and targeted advice to help your organization assess your current circumstances and how to move forward most efficiently and cost-effectively.
Are You MDR Ready?
Take our assessment and get a snapshot of how SMARTCHECK-MDR can help you transition to the more stringent regulation. Results are delivered in an easy-to-view scorecard via the customized dashboard.