Services
Focused technical support for medical device development and FDA-facing work.
Address connectivity, EMC, electrical safety, interoperability, and related cybersecurity considerations while architecture and risk controls can still change. The work is informed by FDA evaluation expectations and focused on avoiding preventable redesign and delay.
Develop a test strategy suited to the device, use environment, and risk. This can include custom plans based on IEC 60601-1-2, AAMI TIR69, ANSI C63.27, and other applicable FDA-recognized standards.
Review test reports, labeling, and technical files before FDA submission. Identify gaps, explain their significance, and recommend practical remediation.
Analyze wireless connectivity and EMC questions in FDA deficiency letters. Trace technical root causes and develop sound responses and mitigations.
Help frame questions, prepare supporting technical material, and support discussions with FDA on connectivity and EMC matters.
Reference points
IEC 60601-1-2
AAMI TIR69
ANSI C63.27
FDA-recognized standards
Contact
Start with the device, network, environment, or evidence need.