DHF Management

Midwest Interventional Systems excels at managing Design History Files (DHF) on behalf of our customers. Our detail oriented and highly organized team, combined with careful adherence to our Quality Management System, to ensure the DHF is compliant and comprehensive. Our programs begin with a detailed project plan, design control deliverables for clear indication of responsibility, design review at the end of each phase, and all necessary verification and validation documentation.

Initial review of the design input (user needs and intended uses) as defined in the Product Specification and/or Customer Specification.

Review of the translation of customer requirements (user needs and intended uses) into engineering requirements. To lock design specifications as described in the Design I/O Matrix and review the associated Engineering documentation such as drawings, and component specifications that reflect these requirements.  Ensure that all ambiguous and / or conflicting requirements have been addressed prior to progressing the design to the design verification / validation stage.

Ensure that the design output meet the design input requirements as defined in the Design I/O Matrix. Design outputs that are essential for the proper functioning and safety of the device are considered to be essential design outputs.  

These are obtained prior to design verification testing through review of the risk analysis documents (DFMEA) and are any element with an RPL of 1 or above. Note: Characteristics with an RPL of 0 are considered to have a negligible impact i.e. no impact on safety / performance of the device and are therefore considered to be non-essential design outputs.  

Design Validation occurs primarily in the Validation Phase to demonstrate that the product conforms to the end user needs and intended uses as defined in the Product Specification. The C3 design review will address any discrepancies arising from the design validation report.

Design Transfer occurs prior to commercialization of the product and demonstrates successful transfer of the device design requirements to production specifications and includes completion of elements such as training, process verification and validation, implementation of process specifications and process controls/monitoring, and closure of design review action items.

This is the final project phase, which drives the launch of the device onto the market. Requirements of this phase include regulatory approvals, DHF compilation and marketing elements. This review must be conducted if product is to be approved for commercialization.

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