Day

May 6, 1997
Bernafon-MAICO Inc. 5/06/97 3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the distribution of audiometers with unapproved software. ECOs do not include a record of software source code changes and obsolete versions are not archived [21 CFR Part 820.100 (a)(2)]. Software source code is not controlled under the document...
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Lack of written procedures to identify quality assurance problems reported in complaints and repair requests; failure of screening repair and serice requests to identify complaints; and failure of engineering change orders to include a record of software source code changes 3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the...
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Cybersecurity Review

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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