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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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Healthcare AI – 2024 Health IT Predictions

Healthcare IT Today

are expected to reach $6 trillion by 2027, cost containment and the push to increased decentralization of care will be a top healthcare priority in 2024. ” Madan Moudgal, Chief Executive Office at Sagility Technologies at Sagility In the landscape of generative AI, governance, privacy, and trust surface as pivotal concerns.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers.

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The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition

Health Law Advisor

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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