Symplr

SEPTEMBER 18, 2023

In 2004, President Bush set a goal for every American to have an electronic health record (EHR) by 2014. The goal was that better and safer care could be delivered through more complete knowledge of a patient that was accessible in a secure repository.

Licensing 52

Licensing Compliance Hospitals 52

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

OCTOBER 18, 2023

While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium. CGMP compliance is the floor and FDA is looking for companies to exceed those standards. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. However, licensed software can be a UCC sale of “goods.”

Governance 52

Governance Payment Systems Hospitals Licensing 52