CONSULTING
Design Control
Laboratory Consulting
Pre-Certification Audits
Regulatory Affairs
Compliance
Quality Assurance
Submission Writing
CE Marking
Product Safety
Market Landscape & Opportunity Assessments
Product Positioning & Messaging Strategy
Licensing & Partnership Strategy

 

 

 

 

MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is 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.

ENVIRONMENTAL MONITORING TESTING SERVICES CONSULTING

 

Submission Writing

• International Dossiers and Amendments for Class IIa, IIb and III Products
• Class III PMAs: New Product Supplements, 30-Day Manufacturing
• 510k Notifications
• Drafting and Submission of an IND Application
• Communications with FDA
• Export Permit Requests

 

 

Download Sample Submission Form (PDF)

Download Sample Submission Form (Word Doc)

pdfHow To Submit Your Sample Submission Form (PDF)

 

BSI Registered

ISO Certificate
(PDF)