GENOMEWEB: Empirical Bioscience Receives ISO 13485:2016 Certification for Medical Device and Quality Management Systems

Empirical Bioscience said this week that it has received ISO 13485:2016 certification for Medical Device and Quality Management Systems, which is an upgrade from its previous ISO 13485:2003 certificate. This new certification more closely aligns with US Food and Drug Administration regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry, the firm said. ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing, and sale of medical devices that are safe and effective for their intended purposes. To receive such a certification, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

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BIOSPACE: Empirical Bioscience Upgrades to ISO 13485:2016 Certification

Empirical Bioscience a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate. This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing and sale of medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

“This certification is further evidence of our commitment to quality and ensures every Empirical Bioscience customer – from research institutions to an OEM customer who purchases custom reagents and complete test kits – receives products and services of the highest standards for product performance, quality, consistency, and reliability,” said Beth Lowe, Quality Systems Manager of Empirical Bioscience. “With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Empirical Bioscience is an organization that customers can confidently rely on to meet and exceed expectations,” said Des O’Farrell, President of Empirical Bioscience.

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PRESS RELEASE: Empirical Bioscience Upgrades to ISO 13485:2016 Certification

Empirical Bioscience, a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate. This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing and sale of medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

“This certification is further evidence of our commitment to quality and ensures every Empirical Bioscience customer – from research institutions to an OEM customer who purchases custom reagents and complete test kits – receives products and services of the highest standards for product performance, quality, consistency, and reliability,” said Beth Lowe, Quality Systems Manager of Empirical Bioscience. “With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Empirical Bioscience is an organization that customers can confidently rely on to meet and exceed expectations,” said Des O’Farrell, President of Empirical Bioscience.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.

MEDICAL EXPO: Kit Streamlines DNA Purification

Designed to offer convenience, speed and reliability, the kit arrives with all the essential components: binding buffer, activation buffer, elution buffer, washing buffer, spin columns and collection tubes. The platform allows for efficient DNA purification in 10 min. It provides maximum recovery of DNA bands from 100 bp to 10 kb that are free of oligonucleotides, nucleotides and polymerase with yields exceeding 80 percent. Based on silica-membrane technology, the extraction kits allow for the binding of DNA in high-salt and elution in a low-salt buffer, and is designed to work with DNA amounts up to 20 µg, so no organic extractions or additional precipitations are necessary. This helps to guarantee high and stable recovery rates. The extracted DNA is suitable for use in most downstream applications, such as T-A ligations, PCR sequencing, restriction enzyme digestion, and other labeling reactions.

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LABORATORY EQUIPMENT: Kit Streamlines DNA Purification

Empirical Bioscience’s EB Pure PCR Purification Kit streamlines the DNA purification process and offers ample recovery of high-quality DNA. Designed to offer convenience, speed and reliability, the kit arrives with all the essential components: binding buffer, activation buffer, elution buffer, washing buffer, spin columns and collection tubes. The platform allows for efficient DNA purification in 10 min. It provides maximum recovery of DNA bands from 100 bp to 10 kb that are free of oligonucleotides, nucleotides and polymerase with yields exceeding 80 percent. Based on silica-membrane technology, the extraction kits allow for the binding of DNA in high-salt and elution in a low-salt buffer, and is designed to work with DNA amounts up to 20 µg, so no organic extractions or additional precipitations are necessary. This helps to guarantee high and stable recovery rates. The extracted DNA is suitable for use in most downstream applications, such as T-A ligations, PCR sequencing, restriction enzyme digestion, and other labeling reactions.

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BIOPORTFOLIO: Kit Streamlines DNA Purification

Empirical Bioscience’s EB Pure PCR Purification Kit streamlines the DNA purification process and offers ample recovery of high-quality DNA.

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LAB BULLETIN: New RNA Kits from Empirical Bioscience Offer Swift and Extensive Purification

Empirical Bioscience announce that they have introduced the EB Pure Total RNA Kit and the EB Pure DNase 1 Digestion Kit for the fast and reliable purification of RNA from cells or soft tissue.

The High-Bind configuration of the EB Pure Total RNA Kit specifically, but reversibly, binds RNA under optimized conditions allowing proteins and other contaminants to be removed. It also allows for the binding of RNA in high-salt and elution in a low-salt buffer, and each column can bind up to 100 µg of RNA, so no organic extractions or additional precipitations are necessary. This helps to guarantee high and stable recovery rates in 20 minutes or less. Extracted RNA is suitable for use in applications such as RTPCR, Northern blotting, poly A+ RNA (mRNA) purification, nuclease protection, and in vitro translation.

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BIOPORTFOLIO: New RNA Kits from Empirical Bioscience Offer Swift and Extensive Purification

Empirical Bioscience announce that they have introduced the EB Pure Total RNA Kit and the EB Pure DNase 1 Digestion Kit for the fast and reliable purification of RNA from cells or soft tissue. The High-Bind configuration of the EB Pure Total RNA Kit specifically, but reversibly, binds RNA under optimized conditions allowing proteins and other contaminants to be removed. It also allows for the binding of RNA in high-salt and elution in a low-salt buffer, and each column can bind up to 100 µg of RNA…

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LAB MANAGER: EB Pure Tissue DNA Kit Offers Rapid and Reliable Extraction of Genomic DNA

Empirical Bioscience announced that they have introduced the EB Pure Tissue DNA Kit, a convenient system that allows for the purification of genomic DNA from animal tissue in 20 minutes or less.

The all-inclusive kit features binding buffer, activation buffer, elution buffer, washing buffer, spin columns, protease solution, and collection tubes. The system’s high-binding configuration specifically, but reversibly, binds DNA or RNA under optimized conditions allowing proteins and other contaminants to be removed. This helps to guarantee high and consistent recovery rates, while simultaneously removing primer-dimers, primers, nucleotides, proteins, salt, agarose, ethidium bromide, and other impurities.

“Our New EB Pure Tissue DNA kit allows researchers to extract genomic DNA in a fraction of the time it would take with other methods,” said Des O’Farrell, president of Empirical Bioscience. “And with a lot less hassle,” he added.

What’s more, since the extraction kits allow for the binding of DNA in high-salt and elution in a low-salt buffer, no organic extractions or additional precipitations are necessary. The extracted DNA is suitable for use in most applications such as, PCR, Southern Blotting, and restriction enzyme digestion.

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BIOPORTFOLIO: Empirical Bioscience’s New EB Pure Plasmid Mini-Prep Kit Offers High-Quality DNA in 30 Minutes or Less

Empirical Bioscience announced the introduction of a new EB Pure Plasmid Mini-Prep Kit today. The kit combines the power of High-Bind technology with alkaline-SDS lysis of bacterial cells to deliver high-quality DNA in less than 30 minutes. The kit’s High-Bind composition specifically, but reversibly, binds DNA or RNA under optimized conditions allowing proteins and other contaminants to be removed. Requiring only 1-5mL of bacterial culture, the kit also isolates high-quality plasma or cosmid DNA for extraction up to 10 kb in length and yields up to….

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