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Medical Devices

Overcoming the Challenges of the Constantly Evolving Global  Environment

Medical device developers increasingly rely on CROs to expedite time to market and reduce the risk of device recalls.

SanaClis is ideally positioned to meet your medical device-specific needs.

Comprehensive Regulatory Experience 

With the full application of the new Regulation 2017/745 (MDR), the EU legislation has introduced and defined the following points:

  • Informed Consent
  • Substantial and Non-Substantial Amendments
  • Specific Rules for Risk Populations (e.g., pediatric population, pregnant or breastfeeding women)
  • Damage Compensation
  • Electronic System (EUDAMED) for the notification and management of the clinical trials (including vigilance and incidents reporting)

    SanaClis has the necessary global resources and in-depth regulatory knowledge to support your approval strategy 
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