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Finished device model ORI-1401-05 requires installation and testing performed by the user/customer. To ensure that devices are properly installed, the test result are sent to Orion and filed for a record of proper installation. Examining 10-installation test records you notice that 3-test result fall outside the acceptable range.
820.170.a manufacturer shall maintain …. appropriate test procedures … so that device will perform as intended
Batch records for ORI-1505 dated 10-14-XX and 10-20-XX have several production steps that were not “signed-off”. Additionally, some of the dates are not included on the batch record.
820.184 DHR for each batch … demonstrate that the device is manufactured in accordance with the DMR …
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Quiz from “21 CFR 820: Subpart A Sec 820.1 Scope” and “FDA Medical QSR Regulation FDA 21CFR: defining CGMPs”
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XXZ Cables manufactures a data transfer cable. In one customer application the cables are being used to transfer data between a hospital medical device and computer for monitoring patient care (neither hardware is manufactured by XYZ). The XYZ data transfer cable is a finished device and subject to FDA regulation.
device under SEC. 201.h (21 U.S.C. 321) a “part or component” (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,). Also, “finished device” 820.3.l device or accessory to any device that is suitable for use or capable of functioning …
HealthEZ is a US-based marketing/sales organization. They are currently importing a Class 2 medical device manufactured in Germany. HealthEZ was required to file a 510-k registration for the device. HealthEZ is NOT considered a medical device manufacturer since they only distribute the medical device.
21 CFR 820.3.O Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
A US-based manufacturer that is ISO 13485 certified will by default meet all of the CGMP requirements of 21 CFR 820.
Does not have the same requirements in many areas including: FDA Reporting of life threatening incidents, Recording and responding to Complaints, Labeling/Installation/Handling, DHR, DMR, etc.
A good place to identify the device design records would be to access the Device History Record which includes or references all of the related design records.
The DHR shows the production history only 820.3.i
A Design Review is used at suitable stages of the design to evaluate the capability of the design to meet the design requirements.
820.3.h
A customer makes a telephone call to complain about a late delivery. This complaint must be recorded according to part 820.
Complaints alledge deficiencies related to: identity, quality, durability, reliability, safety effectiveness or the performance of the device. OTD is NOT a device performance issue. 820.3.b
A justifiable reason for granting a variance from quality system requirements for a given medical device would be when the agency determines that such variance is in the best interest of the public health.
820.1.e.2
Do-It-Rite is an organization that outsources the installation of medical devices in hospitals for device manufacturers. Do-It-Rite is NOT considered a manufacturer since they only install devices.
820.3.o, includes: design, fabricators assemblers, processes, sterilization, installation, etc.
A Design Validation determines whether the medical device will actually work when manufactured to design specifications.
820.3.z.2 objective evidence that device specs conform with … intended use.
A “manufacturer” as defined in the regulation must establish and maintain a quality system.
820.5
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