Swissmedic releases new guidance and adopts the updated EU MIR form
Our regulatory experts bring you up to speed on the European Commission release of a new help text file with information for completing the Manufacturer Incident Report (MIR) form.
Human Factors Validation Testing/Summative Usability Testing
Summative usability testing with Emergo by UL — trusted human factors validation testing expertise to support FDA compliance.
Documentation for Human Factors Validation Tests
Is your human factors validation testing documentation compliant? Learn about key components, including risk analysis, protocols and test reports.
FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot
The Office of Inspections and Investigations (OII), part of the U.S. FDA, will expand its program pilot of unannounced inspections beyond India and China.
European Commission Releases New Manufacturer Incident Report Form and Help Text
Read our regulatory experts’ timely summary of this latest medical device regulatory development from the European Commission
Switzerland Continues Efforts to Recognize Non-European Regulatory Authorizations
The Swiss Federal Assembly voted to approve Motion 20.3211, which mandated the Swiss Federal Council to adopt regulations to allow medical devices authorized by non-European regulators to enter the Swiss market.
Substituting proxy participants for actual intended users in human factors validation testing
An Emergo by UL Human Factors Specialist discusses when it is acceptable to include proxy (surrogate) participants in HF validation testing, the FDA’s perspective on proxy participants and additional considerations to keep in mind when recruiting proxy participants.
Lisanne de Vogel
QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485
The South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System developments.
Using color to differentiate medication labels – 5 guidelines for selecting drug label colors
Emergo by UL human factors specialists share guidelines for using and selecting drug label colors.