|Quality is an important aspect of the Medical Devices industry. Due to the fact that the products are used directly on the patient for the treatment of illnesses or injuries or used for diagnosis, they have to fulfill particular high quality levels.
The medical device manufacturing sector has become more regulated everyday in which significant quality systems and product requirements must be satisfied. This leads to the situation that for the majority of medical devices the implementation of a QM-system is part of the legal requirements.
The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.
|ISO 9001 Quality Management Systems - Requirements
|This standard specifies a set of procedures to demonstrate commitment to quality. Utilized by regulatory affairs professionals and quality managers throughout the world,
ISO 9001 is applicable to all type of companies (manufacturers, services providers…) and industries.
|ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
|This standard was created specifically for medical devices and supplies and is based on ISO 9001. The standard has been made into a tool for the manufacturer to use in creating preconditions through which to cater for the regulatory safety and performance requirements as well as client requirements at various stages of product life.
|ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
|This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.