Services

Medical Devices and IVDs

Real Regulatory has a proven track record in all aspects of medical technology. We will work with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a comprehensive technical file/design dossier application and act as your intermediary with the notified body or regulatory authority.

  • Determination of product classification
  • Preparation and submission of EU Regulatory documentation including Technical Files and Design Dossiers
  • Authoring and update of Clinical Evaluation Reports (CER)
  • Liaison with EU Competent Authorities and Notified Bodies
  • Implementation of MDR and IVD requirements
  • Preparation and submission of registration for product applications
  • Preparation and submission of Clinical Investigation Applications
  • Medical device vigilance and reporting systems
  • Regulatory and manufacturing compliance
  • Strategic and regulatory planning
  • Auditing of Quality & Regulatory systems to ensure compliance to ISO 9001, ISO 13485
  • Regulatory/QMS Gap Analysis
  • Assistance with device labelling requirements
  • Risk Management (ISO 14971)
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