Get your medical devices approved for world markets
  IMT can help your business obtain and certifies to all recognized and harmonized
 medical standards - CB report (IEC std.), CE Marking (EN std.for EUrope), FDA (Food and Drug
News
  Administration for USA, Thailand), SFDA (Chaina) and EMC testing (International) etc.
 
 
 
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
  Medical Devices Electrical Safety:  
  - UL/ANSI 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety
  - IEC/EN 60601-1: Medical Electrical Equipment - General Requirements for Safety
  - EN 60601-1-4: Medical Electrical Equipment - Part 1-4: General Requirements for Safety;
     Collateral Standard: Programmable Electrical Medical Systems
  - CSA C22.2.601-1: Medical Electrical Equipment - General Requirements for Safety
- And more.
 
   
 
   
 

Medical Devices Directive:
  On June 14, 1998, the European Union Medical Devices Directive (93/42/EEC) became mandatory
  for all manufacturers selling medical devices in the European marketplace. Today, all medical
  devices sold in the EU must have the CE Marking affixed to demonstrate compliance to this directive.
  If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law. If you manufacture a Class I Sterile, Class I Measuring, IIa, IIb or Class III device, a Notified Body must be involved in the conformity assessment process to sell your product in the European Union. For Active Implantable Medical Devices, a Notified Body must be involved if your device falls within the scope of this Directive.
   
  Based on the indications for use, all medical devices may be classified according to the rules of Annex IX of the Medical Devices Directive. Please see a map of conformity paths for the Medical Devices Directive.