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	 CCC 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



Life Sciences

Medical Devices

E & E Medicals and consulting

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