Extensive ISO-13485 Scope

Proven Process Medical Device's ISO-13485 certification is extensiveThe scope of our ISO-13485 certification is extensive, covering contract services for the design and development, production and servicing of active implantable and in-vitro diagnostic medical devices. Details of this scope is as follows:


Medical Devices and Active Implantable Medical Devices:

  • Active Implantable Infusion Pumps and Accessories
  • Angiographic Injectors
  • Angiographic Syringes
  • Blood Pressure Monitors
  • Cardiac Assist Devices
  • Catheter Control Systems & Remote Manipulators
  • Computer Aided Detection (CAD) Systems
  • Defibrillators
  • Diagnostic Ultrasound Systems
  • Disposable Surgical Instruments
  • Drainage Systems
  • ECG and EEG Monitors
  • Elastomeric Pumps
  • Endoscopes and Endoscope Reprocessors
  • Electrosurgical Instruments and Generators
  • Guide Wires
  • ICP Monitors
  • Imaging and Monitoring Workstations
  • Infusion Pumps
  • Intraspinal Catheters
  • Intravenous Infusion Sets
  • Medical Software
  • Needles
  • Neurostimulators
  • Pacemakers
  • Patient Monitors
  • Pulse Generators
  • Surgical Instrument Reprocessors
  • Syringes
  • Therapeutic Ultrasound Devices
  • Transdermal Drug Delivery Systems
  • Vascular Access Devices
  • Vascular Catheters 
  • Vascular Introducers

In-Vitro Diagnostic Medical Device Product Groups:

  • Glucose Monitoring Systems
  • In-Vitro Diagnostic Analyzers and Software used in the management, detection or diagnosis of cancer, disease status, immune status, autoimmune status or endocrine disorders