I would start with the markets that your devices will be sold in. This determines the quality system requirements. For example, if you are only marketing the devices in the US, then yoiu are only responsible for meeting the FDA QSR for medical devices. Thus, go through those requirements, and implement what is required to be compliant. Then the same is required for all other markets sold to. Most requirements are based on ISO 13495. ISO 14969 (The guidance to 13485) is a wonderful reference for the intent of the ISO 13485 requirements. FDA has several guidance documents on their website that are helpful, also.
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Timothy White
Leadership, Quality Assurance
Abrasive Technology, Inc.
Lewis Center OH
United States
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