Tag: Health Tech

2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia and ROW

December 16, 2024
Medical Device

USA EUROPE AUSTRALIA BRAZIL CANADA CHINA COLUMBIA CZECH-REPUBLIC FINLAND FRANCE GERMANY HONG-KONG HUNGARY ICELAND INDIA IRELAND ...

Asia, Device Compliance, EU, Global Health Healthcare Standards, Global Trends, Guidance, Health Tech, IVDR, MDR, Med Tech, Medical Device Regulations, Medical Devices, Medical Innovation, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

Adopting a Life Cycle Approach to Software Medical Devices: Regulatory Guidelines by Singapore HSA

April 3, 2024
Biopharma

In March 2024, The document “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach” whose third revision was issued by the Singapore Health Sciences Authority. The document is intended...

Cybersecurity, Health Tech, Healthcare Policy, Healthcare Technology, Medical Device Standards, Post Market Surveillance, Product Registration, Quality Management System (QMS), Regulatory Compliance, Singapore Healthcare, Software Regulations

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