BIOPORTFOLIO: 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.

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GRAND RAPIDS BUSINESS JOURNAL: announced it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems

Empirical Bioscience announced it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, 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.

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.

Continue reading at BioSpace…

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…

Continue reading at BioPortfolio…