ISO 13485, Part 2
Design, EU, ISO 13485, Medical Device File, Quality Management System, Risk Management
This Device Tip was contributed by Judy Martin, an Associate with Bob Duffy Associates. Judy has over 25 years in the medical device and IVD industries, with experience in 510(k) submissions, design control, process improvement, recall management, product labeling development and FDA remediation activities. She has particular expertise in device promotion and advertising, including process development and claims substantiation, and extensive expertise in website promotion and regulatory aspects of social media promotion.
This is the second device tip in a series on the changes in EN ISO 13485:2016. This device tip focuses on changes to the design and development processes.
If your Quality Management System is currently certified as compliant with ISO 13485:2003 (and/or EN/ISO 13485:2012), certification in the EU will expire in February 2019. After February 2019, only certification to the latest edition published in 2016 will be valid in the EU. Any design changes made between now and February 2019 and any new development projects should conform to ISO 13485:2016.
In order to be prepared (and here’s the tip):
Identify and incorporate the updates needed to your design and development (design control) process to ensure continued certification in the EU to EN ISO 13485:2016. Begin using the updated processes as soon as possible to generate objective evidence of conformance to the 2016 standard to prepare for your next certification audit.
There are significant changes to requirements in the design and development (design control) process that need to be considered. This list is not comprehensive, but it includes either new sections of the standard or in the case of risk management, a new approach. You should review the following areas in the 2016 standard to ensure that your Quality Management System is compliant:
- Design transfer
- Change control
- Design and Development File
- Medical Device File
- Risk Management
More Info
There are significant changes found in the 2016 update to EN ISO13485 that will need to be incorporated into your design and development (design control) process in order to maintain certification in the EU. Just a few are listed here:
- Design transfer – there is a new section in the standard outlining the requirements that must be conducted and documented for design transfer. For example, there must be procedures to ensure that design outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet requirements.
- Change control – the requirements for control of design and development changes have been expanded. One significant new requirement is the determination of the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the device and its intended use.
- Design and development file – this is a new requirement for a record for each device type that demonstrates conformity to the requirements for design and development and contains records for design and development changes.
- Medical device file – this is another new record requirement for each device type that demonstrates conformity to the requirement of the standard and compliance with applicable regulatory requirements.
- Risk management – this version of the standard introduces a different approach to risk management from previous versions. It requires application of a risk based approach to the control of the processes needed for the quality management system.