Mansfield, MA (openPR) 1 September 2010

Proven Process Medical Devices Inc., a leading designer of the nation and the manufacturers of Class II and Class III Medical successful completion requirements of ISO 13485:2003 surveillance audit by the notified body TÜV Rheinland. The audit confirmed and renewed Proven Process Medical Devices’ long ISO 13485 and further emphasizes the company’s commitment to excellence in every phase of the development of medical devices and manufacturing. Is the most remarkable thing the vast scope of the ISO certification of the company. The certification covers medical devices, active implantable medical devices and in-vitro diagnostic medical devices.

In the field of medical devices and active implantable medical devices, certification of products includes groups such as vascular catheters, spinal catheters, needles, syringes, vascular-introducer, guide wires, intravenous infusion, vascular access devices, drainage systems, pacemakers, nerve stimulators, pulse generators, defibrillators , equipment to support the heart, the ECG, EEG, and ICP, blood pressure monitors, patient monitors, infusion pumps and implantable active pumping systems, elastomeric pumps, transdermal systems of medicines, disposable surgical instruments, endoscopes, endoscope reprocessing of surgical instruments, tools and RF generators control systems, catheters, diagnostic ultrasound systems, ultrasound therapy devices, imaging workstations and monitoring, computer-aided detection (CAD) software and medical instruments. In-vitro diagnostic product groups in the unit of ISO 13485 in the range of glucose monitoring systems, which includes in vitro diagnostic devices and analysis software.

ISO 13485 is an internationally recognized quality standard that sets the rules of strict requirements management system (QMS) for the design and manufacture of medical devices. increases based on the best of ISO 9001, ISO 13 485 requires attention to known regulatory requirements for the design, development and manufacture of medical products. Good practice first experience with ISO 13485 certification in 2003.

“The breadth of the medical device product lines in our ISO 13485 re-certification covers speaks volumes about our commitment to real and measurable value for each and every stage to make the development of medical devices. It also highlights our understanding of and compliance with quality standards set forth by ISO 13485th We are very proud of the results of this audit according to ISO and to renew it as an opportunity to the culture of our society to quality and excellence, “said Kenneth Fine, President of the devices tested medical procedures.

About ISO ISO is the International Organization for Standardization. It was founded in 1947, in Geneva, Switzerland. Its purpose is to facilitate and support international trade through the development of standards that people everywhere recognize and respect. ISO achieves this through the participation and support of its member organizations represent more than 150 countries. ISO standards tend to support worldwide.

About ISO 13485: ISO 13485 was prepared by Technical Committee ISO 210, which develops responsible for quality management and corresponding general aspects for medical devices

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Proven Process Medical Devices

Info: Founded in 1994, Proven Process Medical Devices is an expert in the design, development, validation and production of class II and III, therapeutic and diagnostic medical devices. The company adheres to a process that has proven itself since its founding in 1994. Concept of the company to customers (sm) Turnkey he can create added value of each and every stage of development of medical devices. Proven Process customers include well-known brands such as Boston Scientific and Pfizer as well as start-up to make a name in the industry.


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Defibrillator