Medical Device Process Validation Articles & Analysis
3 articles found
Central to this journey is the process of validation and verification (V&V), which helps in affirming that the medical device meets its intended requirements and functions safely within the medical environment. ...
The International Organization for Standardization has also established global package validation requirements for medical devices. ISO 11607-2: 2019 provides guidelines for developing and validating sterile medical packaging systems. ...
When it comes to medical devices cleanliness is crucial. All medical devices, whether they are disposable, implantable or reusable, must be cleaned during the manufacturing process to remove oil, grease, fingerprints and other manufacturing soils. ...