Lumisys MammoWorks interactive database

Lumisys 5/12/98 MammoWorks” an interactive database designed for mammography practices and teleradiology devices.

1. Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications [21 CFR 820.70]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that your production process and duplication equipment used to produce your software computer disks for your published products will consistently produce products which meet their pre-determined specifications and quality attributes. Additionally, obsolete manufacturing procedures were disclosed in your disk duplication area.
2. Failure to control procedures for receiving, reviewing, and evaluating complaints [2l CFR 820.l9S]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that the computer software used for monitoring customer complaints and performing other quality system activities will generate and maintain information to properly evaluate customer complaints and contain explanations for reasons not conducting complaint investigations.

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.

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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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