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CE MARKING (EU) 

DIRECTIVES  93/42/CEE  and 98/79/CEE


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


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


GMP, ISO 13485 Quality Systems
ISOplan's quality management system experts plan and project a suitable quality system for your company  in accordance with the ISO 9001, ISO 13485  Click here for details.

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.

CFDA China

JPAL Japan

KFDA Korea

ANVISA Brazil

CMDR Canada

GOST Russia

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world



India Ministry of Health
Middle East 
(
SFDA Kingdom of Saudi Arabia, Iran, Republic of Turkey, Syria) 
Ministry of Health Mexico
Far East (Taiwan, Singapore, Thailand)
Africa (Egypt,Tunisia) 
EVICR.net European vision clinical research

 

















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 22716:2008 (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.