For regulatory and quality consultants
More clients. Fewer late nights.
Allele does the research and first drafts across your client list, with traceable sources you can check, so your time goes to judgment.
Guided, not outsourced.
For regulatory consultants
- Predicate research: a ranked shortlist per client device, with the reasons for each match and recall and MAUDE flags.
- Pathway strategy: class-aware assessments for 510(k), De Novo, PMA or exempt.
- Pre-Sub prep: a first draft of the Pre-Submission for you to review and send.
For quality consultants
- DHF: compiled from the design record, 8 elements for a 510(k).
- Risk management: the hazard, risk and control chain built and kept per device.
- QMSR gap checks: see where a client's quality system falls short.
- Complaint triage: complaints sorted and checked for reportability.
Every client, one workspace.
Switch between client workspaces without mixing them up. Each client's records are isolated at the database level, and you decide what each client can see and sign.
Sources you can review.
Every AI draft carries its source and stays marked unverified until you accept it, so you can check the work quickly and stand behind it.
Pilot access and demos
We're opening early access to a small group of consultants in exchange for feedback. Tell us about your practice.
Or write to katie.j.suarez@me.com