Standards Compliance

Navigation

Standards Compliance

We can guide your company to compliance and certification according to the following standards:

  • ISO 9000: 2015 Quality management systems – Requirements for distribution companies.  We can also adapt your QS to the applicable part of  ISO 13485:2016 regarding  medical device trading.
  •  ISO 13485:2016 - Quality System Standard designed specifically for medical devices. This standard is mandatory for most Class 2a, 2b and 3 medical devices and IVDs in Europe.  We offer specific programs for the transition  from  ISO 13485:2003 to ISO 13485:2016.
  • Canadian Medical Devices Regulation
  • U.S. FDA Quality System Regulations

 

Request information
Request information:
* Request subject:
* Name:
* Surname:
* E-mail:
Phone number:
* Request:
Digita i caratteri visualizzati nell'immagine sottostante
Ricarica