SQA

APRIL 30, 2021

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

HIPAA Journal

JANUARY 16, 2023

One of the reasons why some people approach the topic of AI in healthcare with a degree of apprehension is that different sources offer different definitions of AI. To quote Microsoft´s definitions of the two terms: . It is also the case that some sources confuse AI with Machine Learning (ML), which strictly speaking is a subset of AI.

Governance 62

Governance HIPAA World Health Informed Consent 62

AIHC

FEBRUARY 8, 2024

Governments bear the responsibility to set laws and standards to require or forbid certain practices. Another aspect to consider is compliance to national and state security standards. Governments should also avoid introducing regulations that provide a competitive advantage or disadvantage for either companies or themselves.

Governance 59

Governance World Health Compliance Nurses 59

AIHC

FEBRUARY 8, 2024

Governments bear the responsibility to set laws and standards to require or forbid certain practices. Another aspect to consider is compliance to national and state security standards. Governments should also avoid introducing regulations that provide a competitive advantage or disadvantage for either companies or themselves.

Governance 52

Governance World Health Compliance Nurses 52

SQA

OCTOBER 18, 2023

The following is a summary of a Canadian case report that was evaluated by Health Canada, describing an error associated with confusion about the labelled strength of a mineral supplement: In this case, the prescription was dispensed by the pharmacy using a product labelled as “Calcium Carbonate 500 mg”. Definitions.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). Counterfeit health products are imitations of authentic products. Health Advance Inc.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

SQA

FEBRUARY 26, 2024

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52