Iso 13485 Rework Definition
How can the answer be improved? ISO is an international quality management standard for medical devices. This page presents an overview of ISO and provides a PDF sample of our approach. • Establish your quality management system (QMS). • Document your organization's quality management system. Iso 13485 Definition Of Rework Process. ISO 13485 is an International. ISO Audit Checklist - Download as Word Doc (.doc), PDF File (.pdf), Text File (.txt) or read online. Definitions in Plain English. In the context of this standard, a manufacturer. It doesn’t matter whether that person actually designs. Online sitemap creator.
Organizations often issue advisory notices after their medical devices have been delivered. These advisory notices provide supplementary information about the device or specify actions that should be taken. Advisory notices discuss the use, modification, destruction, or return of medical devices. An authorized representative is a natural or legal person who has received a written mandate from a manufacturer to represent or to act on its behalf within specified legal jurisdictions in all relevant regulatory matters. A clinical evaluation uses clinical evidence to assess and to analyze a medical device in order to verify that it is safe and performs properly whenever it is used as intended by the manufacturer of that device.
A complaint is a negative communication about a medical device that has been placed on the market. Communications can be oral, written, or electronic. They allege that a medical device has a deficiency. Complaints can be about the safety of a medical device. Complaints can be about the quality of a medical device.
Complaints can be about the identity of a medical device. Complaints can be about the usability of a medical device. Complaints can be about the reliability of a medical device.
Complaints can be about the durability of a medical device. Complaints can be about the performance of a medical device. Complaints may also allege that a related service, that affects the use of a medical device, has a deficiency.
Complaints can be about the safety of a related service. Complaints can be about the quality of a related service. Complaints can be about the identity of a related service. Complaints can be about the usability of a related service. Complaints can be about the reliability of a related service. Complaints can be about the durability of a related service. Complaints can be about the performance of a related service.
A distributor is any natural or legal person who furthers the availability of a medical device to the end user. Distributors are part of the supply chain and act on their own behalf. An implantable medical device is a medical device that is partly or totally inserted into the human body or a natural orifice or is used to replace an epithelial surface or the surface of the eye and is expected to stay in use for 30 days or more and can only be removed through medical or surgical intervention.
An importer is any natural or legal person who is responsible for taking a medical device that is manufactured in one jurisdiction and being the first to make it available in another specified jurisdiction. Labelling (or labeling) is written, printed, graphic, or electronic information that is used to identify or describe a medical device, to specify its purpose, or to explain how it should be used. Labelling can be attached to medical devices, containers, or wrappers, or it may simply accompany a medical device or be provided for a device by other means. The life-cycle of a medical device includes all phases from initial concept and design to production and post-production and includes final decommissioning and disposal. In the context of this standard, a manufacturer is any natural or legal person who is responsible for designing or manufacturing a medical device and making it available for use under its own name.
It doesn’t matter whether that person actually designs or manufactures the medical device or has someone else do it on their behalf; they’re still the manufacturer under this definition. Also, anyone who modifies a medical device or changes its intended use and makes it available for use under its own name, without acting on behalf of the original manufacturer, becomes the manufacturer of the modified medical device. Furthermore, anyone who designs or manufactures an accessory automatically becomes a manufacturer under this definition if applicable medical device regulations apply to this accessory. The term medical device manufacturer may also include anyone involved in specification development, production, fabrication, assembly, processing, packaging (or repackaging), labelling (or relabelling), sterilization, installation, or remanufacturing. It may also include anyone who puts a collection of medical devices (or other products) together for medical purposes.
Manufacturers have the legal responsibility to comply with all relevant regulatory requirements in every country or jurisdiction that intends to purchase or use their medical device (unless a Regulatory Authority assigns this responsibility to someone else). Instruments, appliances, implements, implants, machines, software, materials, calibrators, apparatuses, in vitro reagents, and any similar or related articles are defined as medical devices if manufacturers intend them to be used (alone or in combination) for one or more of the following purposes:. To deal with human disease.
To prevent human disease. To diagnose human disease. To treat human disease.
To alleviate human disease. To monitor human disease. To care for human injuries. To diagnose human injuries.
Iso 13485 2016 Checklist Template
To treat human injuries. To alleviate human injuries. To monitor human injuries. To compensate for human injuries. To meet human anatomical needs. To investigate human anatomical issues. To replace human anatomical structures.
Iso 13485 Advisory Notice
To modify human anatomical structures. To support human anatomical structures. To maintain human physiological functions. To investigate human physiological functions. To replace human physiological functions.
To modify human physiological functions. To support human physiological functions. To examine specimens taken from human bodies. To disinfect human medical devices. To support or sustain human life. To control human conception.
Rework Definition Manufacturing
A medical device family is a group of medical devices that share the same basic design, have the same basic intended use and the same basic safety and functional performance characteristics, and were manufactured by or for the same organization. In the context of this standard, a performance evaluation uses data to assess and analyze an in vitro diagnostic medical device in order to establish or verify that it can achieve its intended use. Postmarket surveillance is a systematic process that is used to collect and to analyze data about the experience people are having with medical devices which have been placed on the market. That is outside an organization's quality management system.
According to ISO 13485, when the term risk is used it refers to the need to think about what could potentially happen when a manufacturer fails to meet product safety or performance requirements or fails to comply with applicable regulatory requirements. According to the risk management standard for medical devices, the concept of risk combines two variables: the probability of harm and the severity of harm. According to, risk management uses policies, procedures, and practices to analyze, evaluate, control, and monitor risk. A sterile barrier system is the minimum package that prevents microorganisms from entering thereby allowing uncontaminated products to be provided at points of use. A sterile medical device is a medical device that meets established sterility requirements.
National or regional standards and regulations often define the sterility requirements that sterile medical devices must meet. Praxiom Research Group Limited 780-461-4514 Updated on December 31, 2016. First published on June 30, 2015.
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