Quality & Regulatory

Quality is part of our culture at FHC.  Our Quality System is designed to support our mission to collaborate with our customers to develop and market innovative neurological research, surgical, and therapeutic equipment crafted to be the world's finest.  We have established and maintain a continually improving quality system based on ISO 9001, ISO 13485, the Canadian Medical Devices Regulation (CMDR), the Medical Device Directive (MDD) in Europe and the FDA Quality System Regulations.  Our quality system documents all the processes and procedures we follow to design, develop, manufacture and ship quality products to satisfy our customers' needs.

Key Certifications and Capabilities include:


ISO 9001:2008 through Intertek SEMKO
ISO 13485 through Intertek SEMKO
FDA 510(K) Clearance microTargeting Electrodes
FDA 510(k) Clearance microTargeting Guideline 4000
FDA 510(K) Clearance microTargeting Drive System
FDA 510(K) Clearance microTargeting Drive System Accessories
FDA 510(k) Clearance microTargeting STar Drive System
FDA 510(k) Clearance WayPoint Stereotactic System
EC Certificate for microTargeting Electrodes & Tubes
EC Certificate for microTargetingTM Guideline 4000, WayPoint Stereotactic System & microTargeting Electrode Cable
EC Certificate for Sterile Drapes
Health Canada Medical Device License microNeurography Needle Electrode
Health Canada Medical Device License microTargeting Drive System & Electrodes
Health Canada Medical Device License microTargeting Guideline 4000
Health Canada Medical Device License microTargeting STar Drive System

Please contact Pam Doughty if the document you are looking for is not listed above.  We would be pleased to speak with you. Pam may be reached by calling 207-666-5651 x2251 or e-mail pdoughty@fh-co.com.