What is ISO 13485 Compliance?

Any company involved in the design, development, manufacture, and/or distribution of medical devices requires ISO 13485 certification.

*Source: https://insights.pecb.com/iso-13485-certification/

The cost of ISO 13485 certification will depend on the amount of time and resources that is required to implement the standard within your organization. The cost will also be impacted by the amount of employee training that is required and the duration of your audit. Additional expenses such as application fees and annual management fees may also impact your total cost.

*Source: https://www.nqa.com/en-us/resources/blog/july-2017/costs-of-third-party-certification

Technically, ISO 13486 is not a legal requirement. You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them. Even though ISO 13485 is not required for EU MDR compliance, the EU MDR regulation requires that you have a QMS in place, and the ISO 13485:2016 standard is the only QMS standard listed in the EU list of harmonized standards, so most companies will use the ISO 13485 requirements to implement their QMS.

While the ISO 13485 Medical Devices standard isn’t enforceable by law, many governments around the world, including in the UK, make it a legal requirement for organisations to comply with the Medical Devices Directive (MDD).

*Sources:

• https://advisera.com/13485academy/what-is-iso-13485/
• https://www.reagent.co.uk/everything-you-need-to-know-about-iso-13485/

No. Medical device manufacturers only require ISO 13485 certification. ISO 13485 is specific to the medical device industry and incorporates the quality management system fundamentals of ISO 9001 with some additional requirements.

*Source: https://www.orielstat.com/blog/alignment-of-iso-9001-2015-and-iso-13485-2016/