Predetics solutions

Regulatory programmes for common FDA milestones.

Each programme explains who it is for, what we deliver, what we need from your team and which parts of the timeline we can control.

Concept to Cleared Device

One integrated team for software, evidence and FDA submission.

A written regulatory plan, evidence requirements and Q-Submission package.

Your eligibility case, designation request and FDA filing.

A three-month 510(k) programme covering software, evidence and filing.

Triage deficiencies and prepare a point-by-point FDA response.

QMS procedures, roles, training and initial records for SaMD teams.