ISO 13485 : 2016 is the new Quality Management System for Medical Device Manufacturers

ISO 13485:2016 is the most recent update to the quality system standard specifically for medical device companies. You have until March 2019 to update your current ISO 13485 certificate to the new version.

There are many key differences between ISO 13485:2003/EN ISO 13485:2012 versions and the ISO 13485:2016 version— including an increased focus on risk management, supplier controls, and feedback mechanisms–that need careful attention and early focus to ensure that those in the medical device industry prevent loss of market position or ability to market and sell when the deadline is reached.

We will provide a quick cost-effective and flexible solution to meeting your needs either:

  • In migrating across from one version to another or;

  • Setting up a new ISO 13485 system.

We use fully ISO 13485 and FDA compliant software and document management systems and can implement these into your organization as part of our service.

You will be very pleased with our approach, flexibility and friendly attitude.  We have been in your situation and understand how complex these processes may be - we aim to make it simple and step by step to help you to succeed in your product compliance and systems accreditation.  Contact us now to get started.