Tag: Compliance

Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2025

June 4, 2025
Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

2024 Recap: Consumer Health key Regulation/Guidance in USA, EU, Asia and ROW

December 17, 2024
Consumer Health

USA EUROPE ARGENTINA AUSTRALIA BRAZIL CHINA ISRAEL MALAYSIA PHILIPPINES SINGAPORE SWITZERLAND ul.countries { display:flex; list-style:...

Asia, Compliance, Consumer Health, Consumer Safety, EU, Global Health, Global Trends, Guidance, Health Compliance, Health Innovation, Health Policy, Health Standards., Health Updates, Healthcare Regulations, Medical Regulations, Pharma Regulations, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024

April 3, 2024
Medical Device

USA Accreditation Scheme for Conformity Assessment (ASCA) The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Medical Devices – Europe, Asia and ROW Regulatory News – Feb. 2024

March 5, 2024
Medical Device

EUROPE Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices The Commission, after consulting the Member States in...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Role of Technology in Regulatory Intelligence

October 12, 2023
Digital Health

Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing,...

Artificial Intelligence, Compliance, Health Tech, Healthcare, Healthcare Industry, Regulatory Intelligence

Regulatory Intelligence shows path to the Success in Pharma Industry

July 21, 2023
Biopharma

Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture and release products into the market. Companies have to analyze, monitor and gather the information...

Compliance, Healthcare, Medical Devices, Pharma Industry, Regulatory Intelligence, Regulatory Updates