MediPurpose ISO 13485 Certification Renewed for Third Time
Atlanta, GA, September 28, 2012 --(PR.com)-- MediPurpose(tm), a medical device manufacturer and master distributor, today announced that its ISO 13485 certification has been renewed.
First granted in 2004, this is the third time the medical device company has successfully renewed its ISO 13485 certification.
ISO 13485 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device company to maintain a quality management system (QMS).
To earn ISO 13485 certification, a medical device company needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. For renewal, a thorough re-certification audit by an independent notified body is performed every five years in addition to annual surveillance audits to ensure that the QMS is being maintained according to the standard.
Along with validating MediPurpose's medical device development capabilities and QMS, it also enables the company to use the CE Mark, which permits the company to sell medical products in the European Union.
"The ISO 13485 renewal is a tremendous honor for us," said MediPurpose founder and CEO Patrick Yi. "Both brands in our Lancing Devices product division-our flagship SurgiLance(tm) safety lancet and our newly redesigned babyLance(tm) infant heelstick-were developed by MediPurpose, and the renewal further validates the confidence we have in the superior quality of our medical devices."
Introduced in 1999, SurgiLance has become one of the world's most popular fingerstick devices, with nearly one billion units sold. Known for its safety, comfort and ease of use, SurgiLance offers seven fingerstick devices in a wide range of gauges and penetration depths.
First introduced in 2010, a fully redesigned babyLance was launched in August, earning an enthusiastic reception at its first public presentation at the 2012 National Neonatal Nurses Conference in Chicago earlier this month. babyLance has a number of innovative features and is available in two models, with 0.85 mm and 1.0 mm penetration depths.
For more information about MediPurpose's medical products -- including no-cost samples and pricing -- please visit http://www.medipurpose.com/products.
About MediPurpose
Founded in 1999, MediPurpose is a leading medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance(tm) heel incision device, SurgiLance(tm) safety lancet and MediPlus(tm) advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets.
For more information about MediPurpose's medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com.
First granted in 2004, this is the third time the medical device company has successfully renewed its ISO 13485 certification.
ISO 13485 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device company to maintain a quality management system (QMS).
To earn ISO 13485 certification, a medical device company needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. For renewal, a thorough re-certification audit by an independent notified body is performed every five years in addition to annual surveillance audits to ensure that the QMS is being maintained according to the standard.
Along with validating MediPurpose's medical device development capabilities and QMS, it also enables the company to use the CE Mark, which permits the company to sell medical products in the European Union.
"The ISO 13485 renewal is a tremendous honor for us," said MediPurpose founder and CEO Patrick Yi. "Both brands in our Lancing Devices product division-our flagship SurgiLance(tm) safety lancet and our newly redesigned babyLance(tm) infant heelstick-were developed by MediPurpose, and the renewal further validates the confidence we have in the superior quality of our medical devices."
Introduced in 1999, SurgiLance has become one of the world's most popular fingerstick devices, with nearly one billion units sold. Known for its safety, comfort and ease of use, SurgiLance offers seven fingerstick devices in a wide range of gauges and penetration depths.
First introduced in 2010, a fully redesigned babyLance was launched in August, earning an enthusiastic reception at its first public presentation at the 2012 National Neonatal Nurses Conference in Chicago earlier this month. babyLance has a number of innovative features and is available in two models, with 0.85 mm and 1.0 mm penetration depths.
For more information about MediPurpose's medical products -- including no-cost samples and pricing -- please visit http://www.medipurpose.com/products.
About MediPurpose
Founded in 1999, MediPurpose is a leading medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance(tm) heel incision device, SurgiLance(tm) safety lancet and MediPlus(tm) advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets.
For more information about MediPurpose's medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com.
Contact
MediPurpose
Derek Rudnak
888-808-6494
www.medipurpose.com
Derek Rudnak
888-808-6494
www.medipurpose.com
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