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At the same time the fda sought to harmonize the cgmp regulations with applicable international standards.
Iso medical device manufacturing. Contact us client area consultant area careers newsletter sign up. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization. Deep manufacturing experience infrastructure. Manage quality throughout the life cycle of a medical device with iso 13485.
An organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard. Also the agency believed that it would be beneficial to the public and the medical device industry for the cgmp regulation to be consistent to the extent possible with the requirements for. The most relevant standards to implement for the medical device manufacturing services are iso 9001 iso 13485 iso 14001 iso 50001 iso 45001 and iso 27001. Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services.
Caring about health and safety uncover how iso standards help doctors treat patients and keep people safe at work at home wherever. This changed with the safe medical devices act of 1990 which included product design controls. Iso 13485 and european union medical device regulatory requirements complying with iso 13485 standards and gaining the certification is also a first step towards complying with the european regulations and requirements for medical devices and in vitro diagnostic medical devices eu directives 93 42 eec 90 385 eec and 98 79 eec. 4 develop and maintain procedures for each medical device family each medical device file must contain developed procedures or specify procedures for production and all associated manufacturing processes i e packing inventory keeping safe movement and shipment of packed medical products.
It can also be used by internal and external parties such as certification bodies to help them with their auditing processes. An experienced medical device manufacturer is in a position to proactively help customers deal with the complexity of medical device development saving up a lot of time resources and cost while contributing to making an optimized and efficient medical device.
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