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Wednesday, 05/02/2012 11:45:41 AM

Wednesday, May 02, 2012 11:45:41 AM

Post# of 113927
MMTC ~ There is no way MMTC is not legit when working with agencies like these. IMO there is no way there will not be great demand for the MIT'S.........

Excerpt from MMTC PR:

MIT also demonstrated the ability to detect and identify, within several minutes, the microbes Escherichia coli, Listeria, Salmonella, Staphylococcus aureus, and other pathogenic bacteria. This identification process was verified by North American Science Associates, Inc. ("NAMSA"), an independent and internationally recognized bioscience testing laboratory. The NAMSA Test Report is also available from the Company and, in MIT's opinion, demonstrates the accuracy, speed and cost effectiveness of the System over conventional processes. www.namsa.com


Below is INFO off NAMSA Site:


NAMSA started in 1967 when a glass manufacturer in Toledo, Ohio approached a clinical lab to test polymeric materials for pharmaceutical container testing. The clinical lab passed, but a scientist-entrepreneur took the project on, following methods outlined in the United States Pharmacopeia. Soon thereafter, Science Associates was born, and testing expanded to medical devices and materials. In 1976, Congress authorized FDA to regulate medical devices, and North American Science Associates, Inc. had already been testing such products for 10 years. Regulations continued to evolve and become more complex, and NAMSA has been an integral part in developing domestic and international standards for testing medical devices, materials and combination products over the past 45 years.
Today, in addition to laboratory testing, our services have grown to include expert regulatory, clinical, and compliance services. At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.



Accreditations & Certifications
NAMSA maintains the following:


Regulatory Requirements and Quality in Operations
NAMSA is certified to ISO 13485:2003 and ISO 9001:2008, and is accredited to ISO 17025:2005.
We perform testing according to the requirements defined in 21 CFR 58, 820 (U.S. Food and Drug Administration, Good Laboratory Practices and Quality System regulations).
We operate with full accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
We follow U.S. Department of Agriculture (USDA) regulations.
We submit all testing requiring laboratory animals to an IACUC (Institutional Animal Care and Use Committee).
Protocols and Procedures
All samples submitted to NAMSA are tested according to established written standard operating procedures, or specific protocols or study plans, as appropriate.
Samples are assigned a sequential lab control number which is used on all associated raw data sheets, log books, laboratory notebooks, and NAMSA laboratory reports.
Traceability and test status are maintained and tracked through these control numbers and systems of physical segregation.
Strict laboratory quality guidelines are followed to assure valid data.
Each step of laboratory operations is carefully controlled to assure accurate and reliable testing programs.
Original data are recorded in ink on signed, dated record forms or notebooks and are approved by supervisory personnel.
Upon completion of a study, all data are stored in a central file in permanent archives.
Clients are promptly notified of adverse test results by telephone or facsimile, without charge.
Fees listed for each test include:
One copy of the final report to a designated individual
One copy of the final report and supporting data to NAMSA archives
One invoice to a designated individual or department
Auditing and Review
NAMSA has a robust internal audit program including process-based audits, facility audits, and testing-based audits from an independent quality assurance unit.
Members of NAMSA’s staff are selected and trained for specific job functions.
Laboratory equipment is entered in a central calibration and maintenance program for routine calibration.
Laboratory functions are audited by NAMSA’s quality assurance department staff.
Independent and regulatory auditors routinely visit NAMSA to verify compliance to quality system standards.
Performance of routine tests is monitored by periodic check samples and statistical process control.

They sound very thorough IMO.


U.S. FDA Establishment
http://www.fda.gov/
NAMSA is registered with the CDER and CBER divisions of the FDA. The CDRH branch of the FDA does not allow for registration of contract laboratories and contract manufacturers. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820 as well as inspections by CDER under 21 CFR 211.


Here is the NAMSA Link : http://www.namsa.com/About-Us/Accreditations-Certifications.aspx

Here is MMTC/PR Link: http://finance.yahoo.com/news/Micro-Imaging-Technology-iw-3749820292.html


IMO