ABD has successfully navigated the transition from ISO 13485:2003 to the latest standard – ISO 13485:2016.
ABD is one of only a handful of medical device companies that easily made the transition to the latest standards, majority of these companies are still certified to the old standards. ISO 13485 is the world’s most popular standard for medical device quality management systems.
The ISO 13485:2016 certification was conducted by Tim Barash of British Standards Institution (BSI), the first certification body to achieve accreditation for the issue of quality management certificates against the requirements of ISO 13485:2016. The 3-day audit was conducted last June 13 – 15, 2017 at the Commack, NY facility of ABD.
“This certification to the latest quality management systems is an extremely important recognition of our company’s commitment to upholding the highest quality standards to ensure that our product (Avery Diaphragm Pacing System) improves the quality of life of our patients, comments Linda Towler, CEO of Avery Biomedical Devices.
The Avery Diaphragm Pacemaker is an implanted phrenic nerve or diaphragm stimulator. It consists of surgically implanted electrodes and receivers with an external transmitter and antennas.
It can be implanted either cervically or thoracically using minimally-invasive techniques such as video-assisted (VATS) or thoracoscopic approaches.
The Avery Diaphragm Pacemaker is the only diaphragm pacing system to have full premarket approval (PMA) from the US FDA and CE Marking privileges under the European Active Implantable Medical Device Directive for adult and pediatric use.
In addition, using small implanted radiofrequency receivers rather than electrode wires that pass directly through the skin may decrease the risk of infection and ongoing wound care management issues.
Avery has been commercially distributing Diaphragm Pacemakers since the early 1970’s. Since then, more than 2,000 people have been implanted in over 40 countries establishing an unsurpassed record of safety and reliability. Due to their high reliability and cost effectiveness, the Avery pacers are reimbursed by Medicare and most private and government insurance around the world.
To learn more about the benefits of the Avery pacers for those with a high spinal cord injury, central sleep apnea or diaphragm paralysis, please contact us by mail, phone or through our website.