Top of Page Client compliance with requirements Assist in the selection of a certification body.Provide advice on selecting a certification body based on the client’s policies and strategies for launching its product.Identify countries and regions where regulatory compliance is necessary and identify additional requirements in each country and region.Define the relationship with the currently used quality management system (QMS).Plan timelines and identify “to dos” for the acquisition of ISO 13485 certification.Provide advice on identifying the organizational scope and processes subject to certification and the scope of acquisition.

We assist clients in preparing for and examining their objectives for acquiring certification. Analyze differences between ISO 13485, ISO 9001, the QMS Ordinance, etc.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.Explain ISO 13485 requirements based on the target market.We hold lectures on the requirements for clients wishing to acquire ISO 13485 certification. Top of Page Consulting services provided by SunFlare ISO 13485 requirements Workflow for acquiring ISO 13485 certification SunFlare provides consulting services that are optimized to the individual circumstances of business operators wishing to acquire ISO 13485 certification. It specifies the requirements for conducting quality management and production control for medical devices.īusiness 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. ISO 13485 is an international quality management system (QMS) standard for medical devices. Consulting services provided by SunFlareĪcquiring ISO 13485 certification and its benefits.Acquiring ISO 13485 certification and its benefits.

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