Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

Dot Compliance

JUNE 16, 2022

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Dot Compliance

JANUARY 14, 2022

between 2021, and 2028. From global volatility, intellectual property theft, to strict and evolving regulatory requirements, risks permeate nearly every facet of this sector, posing a constant threat to growth and success, and that’s why risk Assessment framework . It’s currently worth $7.7 Source: [link].

Compliance 52

Compliance FDA Regulatory Compliance Governance 52