Tag: Medical Device Standards

Standards updates for last 6 months

January 21, 2025
Standards

Medical device standards are a set of guidelines and requirements that ensure the safety, effectiveness, and quality of medical devices. These standards are established by various international and...

ANSI Standards, ASTM Standards, Device Compliance, Healthcare Standards, ISO Standards, Labeling, Medical Device Standards, Medical Devices, Regulatory Updates, Sterilization

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