Medical Device Innovation Consortium Awarded $2.8 Million For Cybersecurity Programs
The Medical Device Innovation Consortium (MDIC) announced it has been awarded $2.8 million in funding by the U.S. Food and Drug Administration (FDA) for the expansion of the Case for Quality and medical device cybersecurity programs.
According to a press release, the award will develop and evaluate a variation of the Case for Quality Voluntary Improvement Program pilot (CfQ VIP), formerly known as the CDRH Voluntary Medical Device Manufacturing and Product Quality Program, for medical device manufacturing sites that identify as having quality system issues or have been determined to be out of compliance with the quality system regulations. This variation will assess whether using a quality maturity assessment process that evaluates the execution of a quality system instead of compliance, leads to faster improvements in quality and compliance.