MedTrainer

DECEMBER 7, 2023

Effective management of healthcare compliance in West Virginia requires consistent adherence to both federal and state agency standards. To steer clear of legal or financial repercussions as a result of non-compliance, it’s crucial for organizations in West Virginia to establish robust compliance programs.

Compliance 52

Compliance Licensing Medicaid Medicaid 52

SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022.

FDA 75

FDA Compliance Informed Consent Hospitals 75

SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. 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. Address gaps in existing compliance requirements.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. However, licensed software can be a UCC sale of “goods.” Huntington Ingalls Inc. , 3d 1170, 1173 (9th Cir. 2016) (citations omitted). Accord Stark v. 371, 377 (6th Cir.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

OCTOBER 27, 2022

341 (2001), the U.S. From this, the court concluded the defendants could “comply with both federal and Illinois law by obtaining proof of identity and establishing a donor identification system using photographic identification, a valid driver’s license, or any other non-biometric means.” 2d 808, 812 (E.D. 2013); Heisner v.

FDA 59

FDA Licensing Compliance 59