Brodie Pedersen

Brodie Pedersen has worked in the medical device field since 1999. He assists companies in placing their devices in the marketplace through application of design controls, quality system implementation and regulatory filings with the FDA and FCC.   

 

Brodie has grown his experience throughout his career as an expert in standards development and currently serves as the Vice Chair of IEC SC 62A working to develop future versions of IEC 60601 family of Medical Electrical general standards.  Brodie is the Convener of IEC TC 62A JWG 8 for Emergency Medical System ME collateral standard IEC 60601-1-12, and a participant in the joint working groups for Homecare ME IEC 60601-1-11, and ME Alarms IEC 60601-1-8.

 

He is an Electrical Engineering graduate of NDSU (North Dakota State University).  His career includes work in the EMC facility of TÜV Product Service, Nonin Medical Inc. and Logic PD.  Through these roles he has established skills in Quality Assurance and Regulatory Affairs. Assuring the regulatory compliance, safety and performance of medical patient monitoring technology.  This includes the aspects of software, security, wireless certification, electrical safety, labelling, human factors usability and quality system management.  The regulatory roles include 510(k) submissions, health Canada device licensing, CE marking among other jurisdictions.

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