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EU MDR

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                                                                                                                     Bring 2020 Vision to

                                                                                                                     Your Medical Devices







The new European Union Medical Device Regulation changes fully apply in May 2020. Under the new rules, medical devices in the EU must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and will perform as intended.

Are Your Medical Products EU Reg-Ready for 2020?

Your medical devices need to be prepared for quality system audits and, depending on the type of device, a review of safety and performance documentation. If you’re unsure about how your products stack up, the Clinical Research Strategies team of clinical, science, engineering, and regulatory advisors can assist with the latest requirements to help you comply.

Our highly trained collaborative team offers sponsor-side expertise:
 - Clinical Research Operations, Medical Writing, Engineering, and Data Interpretation of Dozens
   of Medical Device Trials using MEDDEV 2.7.1 Rev 4
 - Literature Review Methodology
 - Gap Analysis
 - Compatibility with your Product Roadmap
 - Nimble. Hands-on Knowledge. Auditors. Trust.

Let’s get to work now! 2020 will be here before you know it. Contact us today.