Tag: Compliance

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

July 4, 2024
Medical Device

USA Guidance on Laboratory Developed Tests: Small Entity Compliance Guide FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests”...

.Device Regulation, Compliance, EU, FDA, Global Health, Guidance, Health Care, June2024, Med Tech, Medical Devices, Regulatory News

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

June 5, 2024
Medical Device

USA Remanufacturing of Medical Devices- Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff The guidance is intended to help clarify...

Compliance, eCTD, Global Health, Health Policy, IVDs, Medical Devices, Medical Technology, Regulations, Regulatory Updates

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

Introduction to Regulatory Intelligence Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines...

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