Acquiring ISO 13485 certification and its benefits
ISO 13485 is an international quality management system (QMS) standard for medical devices. It specifies the requirements for conducting quality management and production control for medical devices.
Business operators that comply with these requirements and acquire ISO 13485 certification are able to establish the basis for compliance with the QMS medical device requirements of many countries and regions, including Japan.
SunFlare provides consulting services that are optimized to the individual circumstances of business operators wishing to acquire ISO 13485 certification.
We hold lectures on the requirements for clients wishing to acquire ISO 13485 certification. As part of these lectures, we:
Explain ISO 13485 requirements based on the target market
Explain ISO 13485 requirements assuming application of the Medical Device Single Audit Program(MDSAP) in Japan, the US, the EU, or any other part of the world
Analyze differences between ISO 13485, ISO 9001, the QMS Ordinance, etc.
Analyze differences between ISO 13485:2003 and ISO 13485:2016
We analyze the client’s current QMS to determine whether it complies with the ISO 13485 requirements. As part of this analysis, we:
Check whethe the client’s current QMS complies with the ISO 13485 requirements and identify nonconformities and additional requirements to be satisfied
Review and provide feedback on documents related to the client’s current QMS
