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 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 13485:2016 & MDSAP
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
FDA 510(k) Clearance MicroTable Platform
EC Certificate for microTargeting Electrodes & Tubes
EC Certificate for microTargeting Electrodes & Tubes
EC Certificate for WayPoint Stereotactic System, microTargeting Guideline 4000, Electrode Cable, & 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 Guideline 4000 LP+
Health Canada Medical Device License microTargeting STar Drive System
Health Canada Medical Device License Digital Display Unit (DDU) for use with Nexdrive by Medtronic
Regulatory Certifications LP+ Mexico
Regulatory Certifications STar Drive Mexico
Regulatory Certifications Guideline 4000 LP+ Saudi Arabia
Regulatory Certifications Electrodes Saudi Arabia
Regulatory Certifications STar Drive Saudi Arabia
Regulatory Certifications Registration Colombia
Regulatory Certifications MSACert Japan
ARTG Certificate Guideline Australia
ARTG Certificate Sterile Insertion tubes Australia
ARTG Certificate Non-sterile Insertion tubes Australia
ARTG Certificate WayPoint Australia
ARTG Certificate Electrodes Australia 
ARTG Certificate Drive System Australia 
ARTG Certificate Sterile Drapes Australia
ARTG Certificate Sterile Cables Australia

Please contact Kelly Moeykens or Craig Pagan if the document you are looking for is not listed above.  We would be pleased to speak with you. Kelly may be reached by calling 207-666-5651 x2195 or e-mail kmoeykens@fh-co.com. Craig may be reached at 207-666-5651 x2137 or cpagan@fh-co.com.