Mansfield, MA– Proven Process Medical Devices Inc., one of the nation’s leading designers and manufacturers of Class II and Class III medical devices, has successfully completed the requirements of an ISO 13485:2003 Surveillance Audit by its notified body TÜV Rheinland. The audit confirms and renews Proven Process Medical Devices’ long-held ISO 13485 certification and further underscores the company’s commitment to excellence at every stage of medical device development and manufacturing. Most notable is the extensive scope of the company’s ISO certification. The certification covers medical devices, active implantable medical devices and in-vitro medical devices.
In the area of medical devices and active implantable medical devices, the certification includes product groups such as Vascular Catheters, Intraspinal Catheters, Needles, Syringes, Vascular Introducers, Guide Wires, Intravenous Infusion Sets, Vascular Access Devices, Drainage Systems, Pacemakers, Neurostimulators, Pulse Generators, Defibrillators, Cardiac Assist Devices, ECG, ICP and EEG Monitors, Blood Pressure Monitors, Patient Monitors, Active Implantable Infusion Pumps and Pump Systems, Elastomeric Pumps, Transdermal Drug Delivery Systems, Disposable Surgical Instruments, Endoscopes, Endoscope and Surgical Instrument Reprocessors, Electrosurgical Instruments and Generators, Catheter Control Systems, Diagnostic Ultrasound Systems, Therapeutic Ultrasound Devices, Imaging and Monitoring Workstations, Computer Aided Detection (CAD) Systems, and Medical Device Software. In-vitro medical device product groups included in the ISO 13485 scope include Glucose Monitoring Systems, In-vitro Diagnostic Analyzers and Software.
ISO 13485 is an internationally recognized standard of quality, which articulates the stringent requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. Based on better-known ISO 9001 standards, ISO 13485 requires heightened attention to the regulatory requirements associated with the design, development and manufacture of medical devices. Proven Process first earned ISO 13485 certification in 2003.
“The breadth of medical device product groups covered in our ISO 13485 recertification speaks volumes about our commitment to adding real and measurable value at any and every stage of medical device development. It also underscores our understanding of and adherence to the quality standards put forth by ISO 13485. We take great pride in the results of this ISO surveillance audit and use it as an occasion to renew our company’s cultural commitment to quality and excellence,” stated Kenneth Fine, President of Proven Process Medical Devices.
About ISO: ISO is the International Organization for Standardization. It was established 1947 and is located in Geneva, Switzerland. Its purpose is to facilitate and support international trade by developing standards that people everywhere would recognize and respect. ISO achieves this purpose through the participation and support of its member bodies representing some 150 countries. ISO standards tend to have worldwide support.
About ISO 13485: ISO 13485 was developed by ISO Technical Committee 210 which is responsible for quality management and corresponding general aspects for medical devices.
About Proven Process Medical Devices: Founded in 1994, Proven Process Medical Devices is expert in the design, development, validation, and manufacture of Class II and Class III therapeutic and diagnostic medical devices. The company adheres to a process that has proven successful since its inception in 1994. The company’s Concept to Customer(sm) Turnkey Service allows it to provide value through any and every step of the medical device development process. Proven Process clients include high profile brands such as Boston Scientific and Pfizer as well as promising start-ups poised to make their names in the industry.
