STRUGGLING WITH YOUR DESIGN HISTORY FILE?

LOOKING FOR THE RIGHT PARTNER THAT

COMPLETES THE FILE FOR YOU ?

The Design History File (DHF) is a compilation of all documents and experimental records that describes the design history of a finished medical device. G-Bio builds and maintains the file during the project process. Finally, the customer owns the complete DHF

G-Bio completes the DHF for you, including the following content:

● Contract (copy)

● Confidentiality agreement (copy)

● Project Plans

● Specification Settings Forms

● Manufacturing Requirements Document

● Feasibility and Optimization plans & reports

● Verification plans & reports

● Validation plans & reports

● Technical Transfer

● Production plans & reports

● Stability plans and reports

● Quality Control and Specification Protocol

● Final Manufacturing and QC documents

● Device Master Record

● Technical settings in detail

● Formal Review Meeting Summary Reports

● Risk Management Reports

● Responsibility assignment matrix (RACI)

● Finalized Trace Matrix

● Calibration protocols

● Data Research and Optimization Studies

● Verification Results

● Validation Results

● Stability Results

● Acknowledgement of DHF receipt