The ISO-13485 is an ISO standard, which describes the requirements for a Quality Management System for the design and manufacture of Medical Devices.

It is an extension of the ISO-9001. Whereas the ISO-9001 focuses on customer satisfaction and continuous improvement, the ISO-13485 focuses on product safety.

Compliance with ISO-13485 is often seen as the first step in achieving compliance with European Regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to the different MDD’s must be assessed before sale is permitted. The preferred method to prove conformity is:
1. the certification of the Quality Management System according ISO-13485 and
2. a Technical Product  File review
by a Notified Body. The result of a positive assessment is the certificate of conformity, allowing the CE mark and the permission to sell the medical device in the European Union.

Due to a lot of scandals like e.g the French breast implants, the regulatory requirements are becoming more and more strictly. But also the high speed technology improvements ask for a clearer definition: e.g.
• Can standalone software be a Medical Device ?
• An App on your mobile phone, that can recognize a skin-tumor, is that a
  Medical Device ?

Argo Consultancy has a lot of experience on Quality Management Systems, on both sides of the QMS-table:
• Setting up Quality Management Systems according to the ISO-13485
• Auditing Quality Management Systems on its compliancy with the ISO-13485
It is evident that sitting on both sides of the table has a lot of advantages for both sides on the table.
(Of course auditing my own work is not allowed).

My expertise:
• Setting up compliant Quality Management Systems:
    • That gives enough details to be helpful in supporting the business
    • That is global enough to prevent from being bureaucratic and not being used
• Motivate people to define the QMS, to work with it and to improve it
• Having seen so many good examples to realize your wishes in a minimum of time
and it fits with my slogan:  

Argo Consultancy: Your Drive to Quality