Regumedic Regulatory Affairs

Regumedic is a company specialized in Regulatory Affairs, Quality Management System and Clinical Research. We offer all the support that the medical device manufacturer needs and we interface between manufacturers, distributors, certification agencies and testing laboratories. We have extensive experience in preparing documents for the Technical File or Product Master Record, such as: • Risk Management File (Risk Analysis and Management); • Usability Documents (Usability Plan and Report); • Biological Risk Assessment including Biological Risk Assessment and Toxicological Risk Assessment; • Post-Market Monitoring (PMS/PSUR - Post-Market) including Post-Market Follow-up (PMCF - Post-Market Clinical Follow-up); • Clinical Evaluation; • Clinical Investigation; • Registration of raw materials in the EDQM (European Directorate for the Quality of Medicines). We also offer services for the revitalization and implementation of the Quality Management System for Good Manufacturing Practices Certificate (CBPF), Good Distribution and Storage Practices Certificate (CBPDA) and ISO 13485 Certification. We assist in the interpretation of regulatory requirements of national and international standards, as well as, we evaluate the GAP to meet these requirements in the Quality Management System and in the Technical File. We prepare all documents necessary for CE Mark Certification in accordance with all requirements of Regulation (EU) 2017/745. We provide 100% customized training according to your demand. We carry out an internal audit, with an ISO 13485 lead auditor, and assist in the treatment of non-conformities. We have specialized and qualified consultants, with deep experience to offer the solution your company needs to market products in Latin America, Europe and other countries. Get in touch with us now for a personalized proposal.