UKCA Post-Market Surveillance Requirements for Medical Devices
UKCA post-market surveillance (PMS) is a legal obligation under the UK Medical Devices Regulations, overseen by the MHRA. It requires medical device manufacturers to maintain a structured system for monitoring device safety and performance after market approval. The...
Introduction to UK Conformity Assessed (UKCA): Requirements
UK Conformity Assessed (UKCA) is the United Kingdom’s product marking introduced on 1 January 2021 after Brexit. UKCA shows that a product meets the health, safety, and environmental protection standards required by UK law. It applies to goods sold in Great Britain...
Risk Assessment in Pharma Industry: A Comprehensive Guide
Risk assessment in pharma industry is a systematic evaluation of hazards, their probability, and severity. It is followed by decisions on control measures. Basically, it is a structured process of identifying, analyzing, and controlling potential hazards that could...