Regulatory Competencies
Medical Device Regulation (EU) 2017/745
Medical Device Regulation (EU) 2017/745
Council Directive 93/42/EEC Medical Device Directive (MDD)
Council Directive 93/42/EEC Medical Device Directive (MDD)
Directive 2014/30/EU EMC Directive (EMCD)
Directive 2014/30/EU EMC Directive (EMCD)
Directive 2014/53/EU Radio Equipment Directive (RED)
Directive 2014/53/EU Radio Equipment Directive (RED)
FCC CFR 47 Part 15
FCC CFR 47 Part 15
FDA 21 CFR Part 11
FDA 21 CFR Part 11
FDA 21 CFR Part 820 and Part 4.
FDA 21 CFR Part 820 and Part 4.
EN/IEC 60601-1-2 EMC for medical devices
EN/IEC 60601-1-2 EMC for medical devices
EN/IEC 60601-1 General requirements for basic safety and essential performance for medical devices
EN/IEC 60601-1 General requirements for basic safety and essential performance for medical devices
EN 60601-2-66 Particular standard for hearing aids
EN 60601-2-66 Particular standard for hearing aids
EN/IEC 62366 Usability Engineering for medical devices
EN/IEC 62366 Usability Engineering for medical devices
EN ISO 14971 Risk Management for Medical Devices
EN ISO 14971 Risk Management for Medical Devices
EN ISO 13485 Quality Management for Medical Devices
EN ISO 13485 Quality Management for Medical Devices
EN 301 489-1, -3, etc. EMC for radio devices / short-range devices in the EU.
EN 301 489-1, -3, etc. EMC for radio devices / short-range devices in the EU.
EN 300 220 radio parameter requirements for radio devices / short range devices in EU.
EN 300 220 radio parameter requirements for radio devices / short range devices in EU.
EN 300 330 radio parameter requirements for radio devices / short range devices in EU.
EN 300 330 radio parameter requirements for radio devices / short range devices in EU.
EN 300 440 radio parameter requirements for radio devices / short range devices in EU.
EN 300 440 radio parameter requirements for radio devices / short range devices in EU.
EN 300 328 radio parameter requirements for radio devices / short range devices in EU.
EN 300 328 radio parameter requirements for radio devices / short range devices in EU.
ANSI C63.4 EMC parameter requirements for radio devices / short range devices in USA.
ANSI C63.4 EMC parameter requirements for radio devices / short range devices in USA.
ANSI C63.10 radio parameter requirements for radio devices / short range devices in USA.
ANSI C63.10 radio parameter requirements for radio devices / short range devices in USA.