Electrical Product Safety
Extensive experience with every major test house, we support pre-screening tests to discover technical risks and formal Electrical Product Safety testing for Technical Standards and Particular Standards. We employ a formal Risk Management submission and Technical Report Format (TRF) to ensure the most efficient results.
A partial list of recent tests we've conducted includes:
IEC 60601-1:2005 (Electrical Safety)
IEC 60601-2:2014 (EMC)
IEC 62304:2006 (Software)
ISO 14971:2007 (Risk Management)
IEC 62366-1:2015 (Usability)
IEC 60601-1-11:2015 (Home Use)
IEC 60601-2-25:2011 (ECG)
IEC 60601-2-24:2012 (Infusion Pump)
IEC 60601-2-2:2017 (High-Frequency Surgical Equipment)
IEC 60601-2-4:2010 (AED)
IEC 60601-1-12:2015 (Emergency Medical Equipment)
Additional Services
Risk Management
Aiding your risk management planning and analyses to support new or existing products.
Software Quality
Providing IEC 62304-compliant deliverables and quality oversight on processes and execution.
Usability
Creating your usability documents, executing the appropriate testing and obtaining certifications.