MedApprove

Jim Greco:

Jim has been in the medical device industry for over 20 years, first in the design of analog circuitry and for the last 17 years in regulatory affairs. In the regulatory capacity he has been CE marking medical and non-medical devices for placement on the market in Europe. As part of this he was deeply involved in electrical safety, standards compliance, electromagnetic compatibility, risk management and related endevours. Jim is on IEC 62DMT22 which writes the particular IEC standards for safety and performance of patient monitoring equipment. Jim is also on the IEC/ISO committees for Non-Invasive Blood Pressure and alarms. Jim was also responsible for seeking product approvals in other countries which have medical device approval requirements (Japan, China, Taiwan, Korea, Russia).

Penny Greco:

Penny has been in the medical device industry for over 20 years for the last 15 in regulatory affairs. Penny's primary responsibility has been submissions to the US Food and Drug Administration (FDA) and the Canadian Therapeutic Products Directorate (TPD). In addition to the actual submission she has experience with classification, listings and site registration. She has successfully gained clearance on dozens of medical devices in the US and Canada