seminar content
Legislative and regulatory overview
- Overview of the legislation
- Organization of the FDA
General FDA requirements
- Registration and Listing
- submission
Access to the US market
- product classification
- Investigational Device Exemption (IDE)
- Premarket Approval Application (PMA)
- 510(k) Premarket Notification
- Identification/UDI
Postmarket Requirements
- Medical device reporting
- recalls
- device tracking
Costs for members of LISA
LISA members are the communities of Ecoplus, Human.technology Styria, LISAvienna and Life Sciences Tirol
€ 290,- per seminar
€ 646,- for all 3 Seminars (14.10., 4.11., 2.12.)
all information excl. VAT
Cost without membership
€ 440, - early bird (up to 4 weeks before)
€ 490 standard (4 to 2 weeks before)
€ 520,- last minute (less than 2 weeks before)
incl. seminar documents as PDF and certificate of participation
€ 1.190 package for all 3 seminars:
all information excl. VAT
Any questions?
Other Partners
This event takes place in cooperation with en.co.tec Schmid KG, Ecoplus, Human.technology Styria, LISAvienna and Life Sciences Tirol.
The event is co-financed by LISA Life Science Austria.
