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.