DHF / DDF
Keep Your DHF / DDF Current and Traceable.
Connect product requirements to verification and validation evidence, and maintain a clear history of design reviews and approved revisions.
DHF / DDF Setup
Start With the DHF / DDF You Already Have.
Bring your existing DHF / DDF into Cytodyme, then review imported requirements and supporting information before approving the initial revision.
Existing File
Upload an existing DHF / DDF to kickstart the record in Cytodyme.
Requirements
Organize clinical and technical requirements in a structured format.
Verification & Validation
Keep verification and validation information with the requirements they support.
Design Reviewers
Select who will review and sign each DHF / DDF revision.
Requirements & Traceability
See What’s Connected to Each Requirement.
See how product requirements connect to verification and validation evidence. Linked protocols and reports keep supporting information available as you review each requirement.
Table View
Review requirements, verification, validation, and supporting information in a familiar matrix.
Trace View
See the relationships between clinical requirements, technical requirements, verification, validation, and source documents.
Design Review
See What Changed Since the Last Design Review.
Compare changes against the previously approved revision, document review decisions, and retain supporting evidence with the signed design review.
Before & After
See what changed from the previously approved revision.
Review Each Change
Accept changes and document comments or action items during review.
Supporting Documentation
Add supporting documentation to the design review when needed.
Still Have Questions?
Still have questions? We’ve got you covered.
If it’s not covered here, reach out or book a demo to see Cytodyme in action.
Can we bring an existing DHF / DDF into Cytodyme?
Yes. An existing DHF / DDF can be uploaded to help kickstart the record in Cytodyme. Your team can then review the imported information, select design reviewers, and complete the required review and approval in the system.
How does Cytodyme manage requirements and traceability?
Cytodyme connects clinical requirements, technical requirements, verification, validation, and supporting documents so teams can see the information associated with each requirement and follow those relationships through the DHF / DDF.
How are changes handled between design reviews?
Cytodyme keeps track of what has changed since the previous design review. Reviewers can see the before and after for each change, review and accept changes, add comments or action items, include supporting documentation, and sign the new revision.
Can the DHF / DDF reference documents managed elsewhere in Cytodyme?
Yes. Requirements can reference documents managed in Cytodyme, allowing teams to move between the DHF / DDF and the documents it references while keeping those relationships connected.
What is the difference between a DHF and a DDF?
DHF, or Design History File, is the terminology traditionally used under FDA’s former Quality System Regulation. Under the FDA’s Quality Management System Regulation, which incorporates ISO 13485:2016, the term DHF is no longer used and ISO 13485 refers to a Design and Development File, or DDF. Cytodyme uses DHF / DDF together to reflect both familiar and current terminology.