Biological evaluation of medical devices
EVENT DESCRIPTION The main scope of ISO 10993 is to protect patients from biological risks arising from the use of medical devices. The standard...
Sterilization Validation and Cleaning Validation
EVENT DESCRIPTION Manufacturers of finished medical devices should provide clear, understandable and reproducible cleaning and sterilization protocols that have been validated to be effective....
Digital Testing for Medical Device
EVENT DESCRIPTION Medical devices and healthcare systems represent a growing risk to hospitals and medical centers. The threat is not only to sensitive data,...
Clinical Evaluation of Medical Devices CER: MDD vs MDR
EVENT DESCRIPTION Medical devices require CE Marking for their commercialization in the European Union. When submitting devices for a CE Mark, manufacturers must provide...
Best Practices for Extractables and Leachables Studies in the Pharmaceutical and Medical Devices Industry
EVENT DESCRIPTION The importance of extractables and leachables testing in the pharmaceutical and medical device industry has grown significantly in the last few years...
Usability -No more the abandoned field
EVENT DESCRIPTION The impact of regulatory requirements in design and post-market phases of medical devices; Usability and usability engineering process in human errors prevention;...