SME Profile

Brian Biersach

Brian is the founder of Medical Equipment Compliance Associates LLC (MECA),  a service provider in the areas of evaluation of medical equipment to IEC/UL/CSA/EN 60601, with Collateral, Particular, and related standards since 2002.


He holds a BS in Biomedical Engineering (MSOE) and a BA degree in Economics (USM). Brian is also a certified ISO9000 and EN46001 Quality Systems Auditor as well as an accredited FDA 510(k) reviewer under the FDA Third Party Review Program at Underwriters Laboratories.


Brian is a frequent presenter at seminars and conducts client training on the IEC/UL/CSA/EN 60601 medical standards as well as training for the Association for the Advancement of Medical Instrumentation (AAMI). He also acts as a US expert for AAMI on IEC / ISO Working Groups for International medical standards writing.

Prior to founding MECA, Brian worked for Underwriters Laboratories Inc. as a Medical Device Services Reviewer and Project Engineer and was primary instructor for their medical seminars.