Our System….. as a Qualified Manufacturer of Medical Devices
A&D products conform to numerous design and manufacturing standards. In addition, to conform to stringent global requirements in Japan and abroad, we received our ISO 9001 Quality System Certification in 1996. An additional certification (ISO 13485) required for design and manufacturing of medical devices was awarded. In 2004, we also received our certification for system qualification, which assures our excellence in providing medical devices to EC countries. By complying with those requirements, we are proud to display the CE marking under the 93/42/EEC Medical Device Directive.
A&D is proud to be a Japan-based global manufacturing company. Our Technical Center is located in Kitamoto, Japan, approximately 40 km norths of Tokyo. Our research and development, in accordance with several governmental requirements (ISO 9001, ISO 14385 and others) is conducted at this location. Our goal is to deliver highest quality at competitive pricing in response to market demands.
A&D Technical Center in Kitamoto , Japan
Our engineers in Kitamoto are responsible for:
– New product development
– Overseeing the activities of our off-shore manufacturing
– Managing service support for our worldwide dealers and sales force
– Implementation of ISO 9001 and ISO 13485, and compliance with the US FDA
– Overall management of our corporate quality program
At A&D, we continuously strive to improve quality. We also are a low cost supplier to remain competitive in the marketplace and yet are known for the highest quality and latest innovations.
Our Expertise as a Leader in Blood Pressure Technology
We are proud to be leaders in blood pressure monitoring in both professional and home-health care markets. As the leading manufacturer in the field, our efforts have been supported and validated by prominent physicians and health care providers around the world.
It is of great importance to have products evaluated and validated in accordance with protocols set by organizations such as the British Hypertension Society (BHS), the Association for the Advancement of Medical Instrumentation (AAMI) and, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (ESH). The protocols of these organizations have become highly regarded standards. In the US, our products meet FDA requirements, facility audits, and regulatory pathways via the 510K and QSR processes.
Due to our commitment to deliver the most dependable and accurate monitors on the market, most of our Blood Pressure Monitors have been validated early in their life cycle. It has become imperative to have the Ambulatory Blood Pressure Monitors (ABPM) evaluated by physicians to verify their accuracy for use in the clinical setting. Our ABPM has gone through a considerable number of evaluations by prominent physicians to further advance accuracy and reliability. The TM-2420 (ABPM) became the standard of its day, while the newer and current version, the TM-2430*, has become the new standard.
In recent years, physicians have come to see the value of monitoring blood pressure at home to treat their hypertensive patients. They regard devices for home use accurate to support their patients continuing care. Consequently, the demand for device validation of personal monitors has increased. At A&D, as leaders in blood pressure technology we are confident in the accuracy of our devices and the ability to fulfill the strict requirements of healthcare professionals. All of our blood pressure monitors are validated internally to comply with varying governmental regulations. A number of our automatic monitors have been validated including the A&D UA-767*, UA-774, UA-704 which were validated and published in accordance with the BHS protocol. Newer versions the UA-631/779, UA-787 was validated under the new ESH protocol. Both have received notoriety for their publications in Blood Pressure Monitoring.
* List of publications:
1) TM-2430: Palatini P, Frigo G, Bertolo O et al. (1998) Validation of the A&D TM-2430 device for ambulatory blood pressure monitoring and evaluation of performance according to subjects' characteristics. Blood Pressure Monitoring. 3: 255-260
2) UA-767: Rogoza AN, Pavlova, TS, Sergeeva, MV. (2000) Validation of A&D UA-767 device for the self-measurement of blood pressure. Blood Pressure Monitoring. 5:227-231
3) UA-779/631: Daniele Longo, Olivo Bertolo, Gianluca Toffanin, Paola Frezza and Paolo Palatini (2002) Validation of the A&D UA-631 (UA-779 Life Source) device for self-measurement of blood pressure and relationship between its performance and large artery compliance' Blood Pressure Monitoring. 7:243-248
4) UA-787: Danile Longo, Gianluca Toffanin, Raffaella Garbelotto, Vania Zaetta, Lucio Businaro and Paolo Palatini Performance of the UA-787 oscillometric blood pressure monitor according to the European Society of Hypertension protocol Blood Pressure Monitoring 2003, 8: 91-95
5) UA-767 Plus: Zhanna D. Kobalava, Loulia V. Kotovskaia, Olga S. rusakova, Lala A. Babaeva Validation of UA-767 Plus device for self-measurment of blood pressure Clinical Pharmacology and Therapy, 2003, 12 (2)
6) UA-774/UA-767 Plus: Paolo Verdecchia a , Fabio Angeli a , Fabrizio Poeta a , Gian Paolo Reboldic, Claudia Borgioni a , Loretta Pittavini b and Carlo Porcellati a Validation of the A&D UA-774 (UA-767Plus) device for self-measurement of blood pressure. Blood Pressure Monitoring 2004, 9:225-229