Tag: Compliance

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
Consumer Health

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

What Pharma Companies need to know about EU MDR Regulations?

July 6, 2023
Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs

How Regulatory Tracking Software Can Help Pharma Companies to Manage Risk

June 15, 2023
Biopharma

Pharmaceutical industry has become increasingly challenging due to the rising in the Risks, issues in the Regulatory department because of the variation of guidelines for each and every country. Regulatory...

Compliance, Healthcare, Pharma, Pharmaceutical, Regulatory, Regulatory Compliance