My core competencies are regulatory navigation within electromagnetic compatibility (EMC) and radio parameter matters for medical devices.
I have 10 years experience from a company providing test and consultancy services to device manufacturers.
I have 3 years experience within R&D, with focus on late stage development and life-cycle mangement of medical devices.
I have experience with the Medical Device Directive / Medical Device Regulation, EMC Directive, Low Voltage Directive, etc. for CE marking in EU and FCC and FDA product authorization in USA.
I regularly work with the following regulatory / legislative frameworks:
- Medical Device Regulation (EU) 2017/745
- Council Directive 93/42/EEC Medical Device Directive (MDD)
- Directive 2014/30/EU EMC Directive (EMCD)
- Directive 2014/53/EU Radio Equipment Directive (RED)
- FCC CFR 47 Part 15
- FDA 21 CFR Part 820 and Part 4.
I regularly work with the following medical device standards:
- 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 60601-2-66 Particular standard for hearing aids
- EN/IEC 62366 Usability Engineering for medical devices
- EN ISO 14971 Risk Management for medical devices
- EN ISO 13485 Quality Management for medical devices
I regularly work with the following radio parameter standards:
- EN 301 489-1, -3, etc. EMC 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 300 440 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.
- 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.