|
|
|
CE
MARKING (EU)
MDR REGULATION 2017/745
IVDR Regulation 2017/746
Medical
Devices
Through its office, ISOplan offers customers European Authorized
Representative Services in accordance with the requirements of the
Medical Device Directives 93/42/EEC.
In
Vitro Diagnostic Devices
Manufacturers of In Vitro Medical Devices exporting their products to
European Union are responsible for meeting the requirements of the
Directive (IVD) 98/79/EEC and appointing an Authorized Representative
in a EU Member state
file:///C:/Users/enric/home_EN.htm
CLINICAL TRIALS FOR
MEDICAL DEVICES
ISOplan
provides to comply with all the Italian regulations,
the clinical protocol, search for the cheapest clinic based
both in the European Union and the United
States, where to perform the clinical trials.
GMP, ISO
13485 e ISO 9001
|
|
|
FDA
UNITED STATES
FDA 510(k),
PMA,
device listing
Both the
510(k) pre-market notification and the PMA Premarket Approval represent
a barrier for many manufacturers. ISOplan assists customers
in preparing the 510(k) and the PMA applications filing it to
FDA.
INTERNATIONAL MEDICAL DEVICE
REGULATIONS
Exporting
to many countries requires new pre market approvals and registrations.
We can offer our qualified assistance in filing the requested
documentation and obtaining the market approval.
|
EU NATIONAL
REGISTRATIONS
MINESTRY OF
HEALTH
Italy-France-Spain
ISOplan assists customers for
the registration in many contries of the European Union and in particular in
Italy. Foreign companies shall be registered
directly into the Database and the Repertoire using the online
functions.
FREE SALES CERTIFICATES
ISOplan assists customers for
treceiving the free sales certificate in many contries of the
European Union and in
particular in Italy
COSMETICS
ISO 22716 (GMP)
ISOplan assists customers for
the registration in the contries of the European Union
FOOD - FOOD SUPPLEMENT
ISOplan assists customers for the
registration in the countries of the European Union, USA
FDA, China, Midle East, Canada.
|
|
Consulting
for medical and healthcare companies
Contact
us
