| The implementation of a quality system is a requirement for any manufacturer of medical devices in the US, regardless of its classification, i.e. whether it needs a 510(k) filing or not. The specific requirements for these systems are defined by the FDA in the form of the QSR (Quality System Ruling). These rules are similar to what is used by the ISO quality system standard, however, with some additional processes and procedures, mainly in the area of complaint handling.
OTech has assisted with the implementation of the QSR quality systems. This implementation is highly customized and depends on what the vendor has in place. It can consist of either a review, for example:
- Documenting existing processes and procedures, using interviews and/or desk top research and map these into the QSR framework.
- Audit policies and procedures as they are created by an organization for compliance.
In case there are no existing processes in place, we can also:
- Add the missing procedures to an existing ISO certified quality environment to meet QSR standards.
- Assist in implementing a system from scratch. We have templates that can be used by vendors to be customized for the system implementation.
These engagements are typically performed based on an hourly charge, whereby we estimate in advance how many hours it would take for the activity.
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