Why Lucent Clinical?

Regulatory Standard Changes are Coming ...

Is Your Business Protected?

The pace of regulatory standard change is accelerating as highlighted by the EU Medical Device Regulation (MDR) and the EU In-Vitro Diagnostic Regulation (IVDR).

The MDR originally provided for a three-year transition period. Due to the global outbreak of COVID-19, full application of the MDR was extended and is now fully applicable on 26 May 2021. 

The IVDR will be fully applicable on 26 May 2022 after a five-year transition period.

Is your business protected with a defensive strategy to preserve your core markets and an offensive strategy to register new devices?

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Let Experience
Be Your Guide

Please contact me by email or follow Lucent Clinical Consulting on LinkedIn to stay updated on regulatory changes that affect your business.

  • kimberly@lucentclinical.com
  • https://www.linkedin.com/company/lucent-clinical