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FDA's Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation | King & Spalding

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document. ....

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FDA Issues Medical Device Production Computer Software Guidance

The FDA has issued draft guidance on computer software assurance for computers and automated data processing systems used in medical device production. ....

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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including. ....

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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including. ....

United States , John Giantsidis , Clark University , Cyberacta Inc , George Washington University , Florida Bar Committee On Technology , Principles Of Software Validation , University Of New Hampshire , Rationale For , Trial Population , General Purpose Computing Platform , General Principles , Applying Human Factors , Usability Engineering , Medical Devices , Electronic Records , Electronic Signatures , Clinical Investigations Under , Florida Bar , Cyber Aux , Juris Doctor , New Hampshire , George Washington , Resource Glossary ,