The ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. Note: On February 11th, 2016, the Food and Drug Administration (FDA) announced that effective Mait will no longer accept ISO 13485:2003 voluntary audit reports issued on or after April 1, 2016. Medical Device Single Audit Program (MDSAP) has also seen Regulatory Authorities stepping forward in their involvement and the impact of the program on their own processes. For companies selling or looking to expand their sales to one or to all of the countries involved in the MDSAP program (Australia, Brazil, Canada, USA, Japan), it is important to know that at a minimum, the requirements of ISO 13485 will be included in the auditing criteria along with only the applicable regulations of the authorities the company is concerned with. In the framework of the Medical Device Single Audit Program (MDSAP), organizations’ Quality Management System can be audited for potentially five different Medical Device markets. What are the benefits of getting ISO 13485:2016 certified? The Medical Device Single Audit Program commonly referred to as MDSAP went a step further: it is built on the ISO 13485 principles and includes those principles as part of the audit criteria. A number of regulatory authorities have adopted the ISO 13485 certification standard as part of their own requirements to enable the sale of Medical Devices on their territory. It is not surprising to see that many jurisdictions recognize or even require that Medical Device manufacturers obtain ISO 13485 certification in order to access their market. ISO 13485 focuses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory requirements. The latest survey conducted by the International Organization for Standardization (ISO) shows that in 2015, the number of ISO 13485 certificates issued worldwide was 26255 The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.

Companies are using compliance to this standard to obtain the certification of their Quality Management System. ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry.

En iso 13485 2016