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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.
Iso medical device manufacturing. At the same time the fda sought to harmonize the cgmp regulations with applicable international standards. 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. All manufacturing process flows including.
This changed with the safe medical devices act of 1990 which included product design controls. For over a decade these regulations primarily focused on manufacturing of medical devices. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization. Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services.
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. An electronics manufacturer can be part of a long supply chain and with an iso certification for medical devices on its side assure customers that its part of the process is held to the highest standards. 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. Deep manufacturing experience infrastructure.
Contact us client area consultant area careers newsletter sign up. Caring about health and safety uncover how iso standards help doctors treat patients and keep people safe at work at home wherever.
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