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8 2018 propeller health the leading digital solution for respiratory medicine has been awarded international organization for standardization iso 13485 2016 certification for medical device quality management systems.
Medical device iso 13485 logo. A quality system and here is why we need iso. Iso 13485 manufacturing is an established quality standard pertaining to medical device manufacturers. Iso 13485 auditor for medical device. To be able to sell your medical devices in europe you need 2 things.
It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices this standard supersedes earlier documents such as en 46001 1993. It provides a framework for companies to meet their customer and regulatory requirements. Propeller s fda cleared medical devices include sensors that attach to inhalers and mobile apps powered by a robust analytics platform helping. Design and manufacture of medical devices.
The name of this standard is. Iso 13485 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. However as with any quality standard it is more a set of general guidelines which every manufacturer applies to their own situation according to their status infrastructure and working conditions rather than a recipe for success. Iso 13485 is a quality management system standard designed for medical device companies.
Beside of medical device manufacturers iso 13485 2016 can be applied from suppliers or external parties providing goods or services for organisations producing medical devices. If you have one to know it should be this one. Iso 13485 is the standard for medical device companies. Medical devices quality management systems requirements for regulatory purposes.
Establish a risk based approach to product development and realization. Being iso 13485 certification compliant shows a commitment to the safety and quality of your medical devices. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization iso standard published for the first time in 1996. Medical device logo iso 13485 internal auditor training online iso 13485 lead auditor training rabqsa certified.
A medical device is a product such as an instrument machine implant or in vitro reagent that is intended for use in the diagnosis prevention and treatment of diseases or other medical conditions. Iso 13485 protecting the integrity of the medical device industry. An iso 13485 certificate gives objective evidence for an organisation that the management system is compliant with the standard. If any requirement in clauses 6 7 or 8 of iso 13485 2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied the organization does not need to include such a requirement in its quality management system.
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