ISO 13485 is the ISO standard for quality management systems specific for companies in the medical and IVD sectors. The latest revision of this standard was issued In 2016.
The main objective of this update is to bring ISO13485 closer to the requirements for quality systems in the main world markets, encouraging global harmonization.
Maytal is able to support manufacturers, importers, distributors of medical devices and IVDs:
  • to implement the Quality System in compliance with the ISO13485: 2016 requirements
  • to perform internal audits, audits to outsourced suppliers evaluated as critical
  • Maytal can assist the company during the certification audit