MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is in compliance with the ISO 13485 quality system, ISO 9001:2008 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

Regulatory Affairs

• US, EU and OUS (non-EU) Regulatory Strategies
• Interacting with EU
• OUS and U.S. Regulatory Documentation
• Pre-market Approvals (PMAs) and Post-Approval Submissions
• Preparation of Clinical Documentation
• Global Regulatory, Clinical and Quality Assurance
• EPA Pesticide Registration