anesthesia & incubators Drager Ventilators

Drager Medizintechnik GmbH, 6-Aug-99, Intensive care ventilators, anesthesia and incubators

1. Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a “Hit List” of top nonconforming components contains 16 record counts for Part number 8601618 DC converter failures compared to 18 record counts for Part number 860168 DC converter failures in the dbase database. The spreadsheet is used for management review of component suppliers for all components.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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