Tag: Medical Device Standards

Standards updates for last 6 months

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

Biopharma

whose third revision was issued by the Singapore Health Sciences Authority. The guideline is designed to cover software of all Risk Classifications, covering regulatory obligations throughout the entire...

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