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 European Regulatory documentation including Technical Files and Design Dossiers
• Authoring and update of Clinical Evaluation Reports (CER)
• Liaison with European and UK Competent Authorities and Notified Bodies
• Implementation of EU MDR and IVDR requirements
• Implementation of UK MDR 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)