Estenda Solutions Achieves ISO 9001 Quality Management and ISO 13485 Medical Device Certification
Conshohocken, PA, July 18, 2013 --(PR.com)-- Estenda announced today that the company has achieved both ISO 9001:2008 and ISO 13485:2003 certification. This independent certification validates Estenda’s long standing commitment to quality and affirms that Estenda’s Quality Management System (QMS) provides a solid foundation for their client’s health care software and medical device development initiatives.
“Achieving these certifications is another important plateau in Estenda’s ten year history. We are pleased that these certifications will greatly reduce the internal audit burden our clients face when selecting small, innovative firms like Estenda for major development projects. Nearly all of our client’s products eventually require international regulatory approval of one form or another. We believe Estenda’s certified compliance to these globally respected ISO standards will result in a more efficient regulatory approval path for our clients,” said Drew Lewis, President/CEO and co-founder of Estenda.
ISO 9001 is an International Quality Management System Standard that specifies requirements within which an organization demonstrates its ability to consistently provide product or service to meet customer and legal requirements, enhancing customer satisfaction and opening the way to continual improvement.
ISO 13485 is an extension of ISO 9001 focused specifically on medical device manufacturers, their suppliers and subcontractors. Achieving 13485 compliance allows Estenda to take on full responsibility for the design, creation and validation of software solutions for new and existing customers which including Fortune 100 companies, start-up medical device manufacturers and numerous academic research partners.
“Regulatory bodies here in the US and abroad are increasingly turning their attention to software, whether it’s EMRs, care management solutions, device integration, or mobile software it’s on their radar. In response, customers expect and demand their partners comply to industry best practices. Achieving certification allows Estenda to meet the needs of a growing healthcare software market place,” said Richard ‘RJ’ Kedziora, co-founded of Estenda.
About Estenda: Estenda Solutions is a global project consulting and software development firm focused on bringing innovative healthcare initiatives from concept to reality. Estenda Solutions collaborates with healthcare providers, research professionals and industry creating innovative solutions. Estenda’s goals are to continually innovate and provide tools to enable better patient care and management. Working with both large and small organizations and the individual researcher, we enjoy the challenge of helping our client’s initiatives grow. Estenda has a rich history of work in chronic disease management, patient-medical home solutions, public health, tele-medicine and clinical decision-support designing, developing and deploying intelligent, integrated patient care and management solutions. For more information, visit www.estenda.com
“Achieving these certifications is another important plateau in Estenda’s ten year history. We are pleased that these certifications will greatly reduce the internal audit burden our clients face when selecting small, innovative firms like Estenda for major development projects. Nearly all of our client’s products eventually require international regulatory approval of one form or another. We believe Estenda’s certified compliance to these globally respected ISO standards will result in a more efficient regulatory approval path for our clients,” said Drew Lewis, President/CEO and co-founder of Estenda.
ISO 9001 is an International Quality Management System Standard that specifies requirements within which an organization demonstrates its ability to consistently provide product or service to meet customer and legal requirements, enhancing customer satisfaction and opening the way to continual improvement.
ISO 13485 is an extension of ISO 9001 focused specifically on medical device manufacturers, their suppliers and subcontractors. Achieving 13485 compliance allows Estenda to take on full responsibility for the design, creation and validation of software solutions for new and existing customers which including Fortune 100 companies, start-up medical device manufacturers and numerous academic research partners.
“Regulatory bodies here in the US and abroad are increasingly turning their attention to software, whether it’s EMRs, care management solutions, device integration, or mobile software it’s on their radar. In response, customers expect and demand their partners comply to industry best practices. Achieving certification allows Estenda to meet the needs of a growing healthcare software market place,” said Richard ‘RJ’ Kedziora, co-founded of Estenda.
About Estenda: Estenda Solutions is a global project consulting and software development firm focused on bringing innovative healthcare initiatives from concept to reality. Estenda Solutions collaborates with healthcare providers, research professionals and industry creating innovative solutions. Estenda’s goals are to continually innovate and provide tools to enable better patient care and management. Working with both large and small organizations and the individual researcher, we enjoy the challenge of helping our client’s initiatives grow. Estenda has a rich history of work in chronic disease management, patient-medical home solutions, public health, tele-medicine and clinical decision-support designing, developing and deploying intelligent, integrated patient care and management solutions. For more information, visit www.estenda.com
Contact
Estenda Solutions
Richard 'RJ' Kedziora
610 834 2908
www.estenda.com
Richard 'RJ' Kedziora
610 834 2908
www.estenda.com
Contact
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