Competencies

My core competencies are 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:

  • 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.