E & E Medicals And Consulting

When one considers a group of knowledgeable and experienced professional engineers, medical device and pharmaceutical regulatory consultants, quality assurance and reliability experts, merged with a talented sales team dedicated to online medical supplies, what you get is E&E Medicals and Consulting. We have well-established partners in the EU, Asia, and USA. We have the most exceptional access to a team of consultants who are very experienced with the U.S. Food and Drug Administration (FDA) and the healthcare industry. E&E Medicals provides the following services: Medical Device and Diagnostics o Investigational Device Exemption (IDE) o Premarket Notification 510(k), DeNovo, PMA o Establishment Registration o US Agent for Foreign Establishments Drugs / Biologics / Pharmacovigilance o Investigational New Drug (IND) Application o New Drug Application(NDA) o Abbreviated New Drug Application (ANDA) o Biologics License Application (BLA) o Drug Master File (DMF) Submissions o Chemistry, Manufacturing, and Control (CMC) International Regulations, Approvals, Licensing and Compliance o Mark Approval o CE Mark Approval o EU MDR/IVDR Technical Documentation o Post-market Compliance o FDA 483 Warning Letter/Recalls and Remediation o Canada License Applications o Regions: APAC, LATAM, EMEA, ASEAN, META HEALTHCARE CONTINUOUS IMPROVEMENT o Reliability o Six Sigma - Healthcare QUALITY ASSURANCE o Medical Devices o Audits o Reliability o Quality System Regulation o Quality Management System Implementation QUALITY SYSTEMS IMPLEMENTATION, ISO CERTIFICATION o ISO 13485 Quality System Registration o ISO 14971 Device Risk Management o ISO 9001 Quality Management System o Free ISO 13485:2016 Gap Analysis Tool o Free ISO 9001:2015 Gap Analysis Tool