Biolife LLC Receives ISO 13485:2003 Certification
Published Tuesday, June 2, 2009
by Patti Norris
FOR IMMEDIATE RELEASE
CONTACT: Andrew McFall
Director of Marketing and Communications
(800) 722-7559 Extension 117
Email: andrew.mcfall@biolife.com
Biolife LLC is pleased to announce that it has received ISO 13485:2003 certification from SAI Global. ISO 13485 is an
internationally recognized standard, published in 2003, that specifies the requirements for a comprehensive quality
management system for the design and manufacturing of medical devices. Through this standard, an organization
must demonstrate its ability to provide medical devices and related services that consistently meet customer and
regulatory requirements. ISO 13485:2003 also places emphasis on the use of procedures to regulate and control how
activities and processes should be performed. “Biolife has documented what we should be doing as a company, and
we do what is documented,” said Biolife President, Sam Shake. “The ISO auditor has reviewed our processes and
confirmed that they meet regulations. All Biolife team members worked very hard to obtain this certification. It is a
significant milestone for us because it demonstrates to our customers and potential business partners that we are a
company with high quality standards in place.”
More than 6000 medical device organizations in over 70 countries have been certified to the ISO 13485:2003 standard. It
is a primary objective of the international standard to provide a unified set of medical device regulatory requirements to
facilitate entry into global markets. Now that it is ISO 13485-certified, the next step for Biolife is to seek CE Mark
approval. The CE mark will allow the organization to establish its global presence beyond North America.
About Biolife, LLC
Biolife, L.L.C. is a privately owned company that manufactures and distributes a patented topical powder that stops
bleeding and forms a seal over an external bleeding wound or an access site. Founded in 1999 and headquartered in
Sarasota, Florida, Biolife’s powder products are sold to leading hospitals, occupational workplaces, professional
sports teams and consumers across the country. The company’s mission is to develop and market products that
improve the consumer’s quality of life. For more detailed information on Biolife, LLC please visit the official company
website at http://www.biolife.com.
About SAI Global
SAI Global applies information worldwide to help organizations manage risk, achieve compliance and drive business
improvement. It provides access to standards and other technical and regulatory information, compliance solutions,
business improvement training and independent verification and certification services.
Headquartered in Plainsboro, NJ, the SAI Global Compliance Division (www.saiglobal.com/compliance) brings a global
view and global capabilities to comprehensive compliance, ethics, AML (anti-money laundering), information security
and privacy solutions.
Published Tuesday, June 2, 2009
by Patti Norris
FOR IMMEDIATE RELEASE
CONTACT: Andrew McFall
Director of Marketing and Communications
(800) 722-7559 Extension 117
Email: andrew.mcfall@biolife.com
Biolife LLC is pleased to announce that it has received ISO 13485:2003 certification from SAI Global. ISO 13485 is an
internationally recognized standard, published in 2003, that specifies the requirements for a comprehensive quality
management system for the design and manufacturing of medical devices. Through this standard, an organization
must demonstrate its ability to provide medical devices and related services that consistently meet customer and
regulatory requirements. ISO 13485:2003 also places emphasis on the use of procedures to regulate and control how
activities and processes should be performed. “Biolife has documented what we should be doing as a company, and
we do what is documented,” said Biolife President, Sam Shake. “The ISO auditor has reviewed our processes and
confirmed that they meet regulations. All Biolife team members worked very hard to obtain this certification. It is a
significant milestone for us because it demonstrates to our customers and potential business partners that we are a
company with high quality standards in place.”
More than 6000 medical device organizations in over 70 countries have been certified to the ISO 13485:2003 standard. It
is a primary objective of the international standard to provide a unified set of medical device regulatory requirements to
facilitate entry into global markets. Now that it is ISO 13485-certified, the next step for Biolife is to seek CE Mark
approval. The CE mark will allow the organization to establish its global presence beyond North America.
About Biolife, LLC
Biolife, L.L.C. is a privately owned company that manufactures and distributes a patented topical powder that stops
bleeding and forms a seal over an external bleeding wound or an access site. Founded in 1999 and headquartered in
Sarasota, Florida, Biolife’s powder products are sold to leading hospitals, occupational workplaces, professional
sports teams and consumers across the country. The company’s mission is to develop and market products that
improve the consumer’s quality of life. For more detailed information on Biolife, LLC please visit the official company
website at http://www.biolife.com.
About SAI Global
SAI Global applies information worldwide to help organizations manage risk, achieve compliance and drive business
improvement. It provides access to standards and other technical and regulatory information, compliance solutions,
business improvement training and independent verification and certification services.
Headquartered in Plainsboro, NJ, the SAI Global Compliance Division (www.saiglobal.com/compliance) brings a global
view and global capabilities to comprehensive compliance, ethics, AML (anti-money laundering), information security
and privacy solutions.
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