Can I paste my eSTAR attachment index?
Yes. Include section names, file names, report status and validation issues, but use FDA’s current official eSTAR separately.
Free package and portal workpaper · No signup
Medical Device Submission Package Readiness Preflight
A strong dossier can still fail operationally because product names conflict, files are unsearchable, reports are drafts, signatures are missing, or portal answers do not match attachments. Preflight the package before final release.
Check content and attachments
Start with the product facts and evidence you actually have.
Find file and consistency issues
Separate supplied evidence, public sources, and assumptions.
Build an owner-ready release list
Download a branded workpaper with gaps and next actions.
Preflight a medical device submission package
The agent checks the package as an operational submission set: content, consistency, files, attachment references, signatures, validation, and portal readiness.
Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
How to get a useful workpaper
- 1State the authority, submission type, applicant, product and intended filing date.
- 2Paste the attachment index plus file names, revisions, approvals, signatures, validation messages and open evidence.
Continue from this workpaper
Carry the same product context into a related search, evidence review, or planning task.
Medical Device Submission Package Readiness Preflight FAQ
Does it inspect actual PDFs?
The free version uses copied file and document information. Preserve page and section references in the paste when available.
Will it flag inconsistent names and models?
Yes, when the inconsistent values appear in the supplied material.
Can it submit the package?
No. Submission remains with the user or an authorized regulatory representative.