ISO 80369-1: An Essential Guideline to reach Compliance
ISO 80369-1 entitled “Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements” specifies the design,…
Process Validation Series: Installation Qualification
In regulated industries like medical device manufacturing, ensuring product quality and compliance with stringent regulatory standards is paramount; within the…
IEC 60601-1-11 : Requirements for Medical Equipment to be used at home
In recent years, the number of medical devices designed to be used within a home environment has increased substantially; this…
ISO 10993 Cytotoxicity Evaluation of Medical Devices
The evaluation of the cytotoxicity of a medical device based on ISO 10993 is one of the key milestone for…
Design Verification vs Design Validation: What are The Differences?
Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical…
21 CFR Part 11: Requirements for Electronic Records and Signatures.
Introduction of 21 CFR Part 11 Requirements FDA 21 CFR Part 11 defines the requirements for the management of electronic…
ISO 10993-1 : Biocompatibility Evaluation for Medical Devices
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities…
Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software .…
Statistic for Quality Management Systems: ISO and FDA Requirements
The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and…