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ISO 13485

Medical Devices - Quality Management Systems Requirements for Regulatory Purposes

A successful ISO 13485 project will require your company’s commitment to provide resources and complete goals and homework which arise as the result of the workshops shown in the menu below.  Registration through a third-party registrar cannot be achieved without it.  Generally, nine to twelve months is the norm for completing ISO 13485 Implementation, although it can be accomplished in six months.  WCH cannot stress enough how important it is for your company to commit to the project in order to be successful.


It is possible to implement several standards at the same time.  Examples include:  ISO 13485, ISO 14001, and ISO 45001, or ISO 13485 and AS9100, or ISO 9001 and ISO 13485.  ISO 13485 can be integrated with FDA 21 CFR 820 cGMP Requirements.

The following menu is representative of the consulting services that may be provided during an implementation project.

It is also possible to request any of these services separately on an as needed basis.

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Business Management Consulting

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AS9100 - IATF 16949 - ISO 9001 - ISO 13485 - ISO 14001 - ISO 17025 - ISO 27001 - ISO 45001

Blueprint Reading, cGMP, Core Tools, QA Inspector, Statistical Process Control, Supplier Audits

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