MedicSense provides effective Global Regulatory Affairs services for all stages of medical device product development and lifecycle management, including:

  • Regulatory DUE Diligence.
  • Strategic Regulatory Consulting.
  • FDA 510(k), 510(k) De Novo, PMA. Pre Submissions, Pre IDE and IDE submissions.
  • Listing and registration with the FDA.
  • EU CE Mark activities for the Directives (AIMD, MDD and IVD) and Regulations (MDR, IVDR).
  • Liaison with FDA, Notified Bodies, Registration Bodies and Competent Authorities.
  • Submission and registration of products in the Far East, Oceania, Israel, South America and other non-EU countries.
  • U.S. Agent services provided by our American subsidiary, MedicSense USA.
  • EU Authorized Representative services.
  • Development of product-related Regulatory Plans and Product Verification and Validation.
  • Implementation of technical aspects of both Standards and Testing as well as certification issues.
  • Investigation and reporting of incidents and adverse events.
  • Mock Audits (FDA QSR, Health Canada, EU Directives and Regulations, EN/ISO 13485, MDSAP etc.).
  • Handling Risk Management processes in accordance with EN ISO 14971
  • Information Security Management Systems (ISMS) consultancy services based on ISO 27001 and ISO 27799
  • Dedicated technical and scientific writing.