FED STD 209E IS0 14644 Class 100 Quality Consulting Regulatory Consulting Biocompatibility

MicroMed Laboratories
1129 N. McDowell Blvd
Petaluma, CA 94954
Phone: 707-782-0792
Fax: 707-765-2360
Email: info@micromedlabs.com
Website: www.micromedlabs.com

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Download Sample Submission Form (PDF)

Download Sample Submission Form (Word Doc)

Download Test Index (PDF)

ISO Certificate
(PDF)

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.

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CER Monitoring and Design

Laboratory Testing

Consulting and Training

	Viable Air Monitoring
	Surface Monitoring
	Passive Air Monitoring
	Non-Viable Particulate Monitoring
	Cleanroom/Controlled Environment Validation
	Cleanroom/Controlled Environment Modifications
	Cleanroom or CER Validations
	Equipment Validations
	Cleanroom Leasing

	Bioburden Testing
	Sterility Testing
	VDmax Validation
	Pyrogen (LAL) Testing
	Biological Indicator Population Verification
	Microbial Identification
	Cytotoxicity Testing
	Shelf Life Studies and Package Integrity Testing
	DNase/RNase Testing
	Cleaning and Disinfection Validation
	(FTIR) Fourier-transform infrared spectrometer
	Microbiological Water Testing
	Autoclave Cycle Validation
	Autoclave Cycle Qualification
	Environmental Chamber/Oven IQ/OQ/PQ
	Rent-A-Tech
	Class 100 Controlled Environment Clean Room Leasing
	Specialized Microbiology Testing
	Biocompatibility Studies
	Sterilization

	Design Control
	Laboratory Consulting
	Pre-Certification Audits
	Regulatory Affairs
	Compliance
	Quality Assurance
	Submission Writing
	CE Marking
	Product Safety
	Gowning Training
	QSR Training
	Good Laboratory Practice Regulations Training
	Basic Microbiology in the Manufacturing Environment Training
	GMP Training
	Market Landscape & Opportunity Assessments
	Product Positioning & Messaging Strategy
	Licensing & Partnership Strategy

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MicroMed Laboratories
1129 N. McDowell Blvd
Petaluma, CA 94954
Phone: 707-782-0792
Fax: 707-765-2360
Email: info@micromedlabs.com
Website: www.micromedlabs.com

View map and get directions to our facilities: