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Barton Carey Medical Products 4/3/96 our Investigator determined that your firm manufactures vascular and burn compression garments. These garments are devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The Inspection revealed that your devices are adulterated in that, the methods used in, or the facilities or controls...
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PIE Medical Equipment 4/1/96 Netherlands ultrasound 1. Failure to maintain records documenting that production and quality assurance measurement equipment is routinely calibrated, inspected, and checked according to written procedures and to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required...
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Cabrini Medical Center Blood Bank 2/8/96 14. Failure to maintain written standard operating procedures for the blood bank’s computer system that include: integration of the computer into daily operations; reverting to manual operations when the system is not functioning; control of changes in hardware and software; security procedures to prevent unauthorized access; and maintenance procedures...
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McGHAN Medical Corporation 2/16/96 mammary prostheses The validation of the computerized dip timer system for software version [purged word] and [purged word] fails to assure that the previous files are overwritten when the maximum number of files [purged word] is reached. This is demonstrated by the fact that there was no verification of the file...
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2/14/96 ADAC Laboratories Pinnacle Radiation Therapy Planning Software 83 tapes recalled Due to a software problem, the wedge scatter fields will be calculated incorrectly if the wedge filter is not square. Software version 2.1F
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Ionetics 1/29/96 electrolyte analyzers 1. Failure to ensure specification changes are subject to controls as stringent as those applied to the original specifications of the device [21 CFR 820.100(a)(2)]. For example, your firm failed to document and approve changes made to components and software for your electrolyte analyzers.
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“Information Technology – Software Lifecycle Processes” and issued August 1995. This document was the basis for development of the AAMI Medical Device Software Development Standard and was one of the first software standards recognized by FDA for submission purposes. It can be ordered directly from the IEC at www.iec.ch. Just go to their web store...
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http://www.fda.gov/cdrh/comp/guidance/fod456.pdf
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The paper at the link provided was written by Mark Paulk of the SEI. It compares ISO 9001 and the Capability Maturity Model (CMM). Although there are some differences between ISO 9001 and the FDA Quality System Regulation, both in content and enforcement, this paper may be helpful for medical device software developers involved in...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one...
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