FDA, MDR, CMS, and ONC pathway work for medical-device companies, ISVs, payers, hospitals, ministries, and founders. Run by people who have filed the submission.
A written memo names the pathway, the class, the predicate or De Novo case, the timeline, and the budget before the build resumes.
FDA Q-Sub and notified body application packs written to the question set the reviewer will actually open the meeting with.
ISO 13485, IEC 62304, ISO 14971, and 21 CFR Part 820 gap analysis with a remediation plan that has owners and dates.
510(k) or De Novo timeline mapped against NTAP, CPT, HCPCS, and MAC coverage windows so reimbursement is not stranded.
The advisor on the call has signed a submission. Reviewer questions, deficiency letters, and IDE detours are familiar ground.
After submission, the same team handles AI requests, deficiency responses, and notified body follow-ups until the certificate clears.
Outcomes from the FDA, MDR, CMS, and ONC pathways the Life Value team has run, and the ones currently in review.
Intensive pre-submission work, then standby through review.
FDA SaMD pathways filed across the Life Value portfolio.
MDR transition deadline our medical-device buyers are working against.
Six to twelve weeks of intensive pre-submission work, then standby through the review cycle, run by an advisor who has filed the submission.
.svg)
Talk to a product strategist. No pressure. Just clarity.
From regulatory updates to product design frameworks, we share practical, actionable guidance to help healthcare teams build with clarity and confidence.
We’ve answered the questions we hear most from healthcare teams, founders, and partners. Don’t see yours? Reach out: we’re here to help.
The pathway is set by intended use, indication, and risk class, not by the marketing claim. A wellness claim stays outside FDA. A diagnostic or therapeutic claim is a medical device. Class II with a predicate maps to 510(k). No predicate but moderate risk maps to De Novo. High-risk life-supporting AI maps to PMA. We write the pathway memo with the predicate analysis, the class justification, and the pre-submission meeting question set the FDA reviewer will actually engage with.
Medical-device companies still on legacy MDD certificates need a notified body slot, a Class IIa, IIb, or III technical file rebuild, and a Quality Management System aligned to ISO 13485 before the deadline. Notified body capacity is the binding constraint, not the technical file. We help shortlist notified bodies by class and product code, prepare the application, and run the technical file gap analysis against MDR Annex II so the review cycle does not restart.
FDA clearance is permission to market. CMS coverage is permission to get paid. The two run in parallel. NTAP applications need clinical evidence and a cost case ready inside the FDA review window. A new CPT or HCPCS code set submission runs on the AMA or CMS calendar. MUE and coverage determinations sit with the MACs. We map the FDA milestones against the CMS submission windows so the launch is not stranded without reimbursement.
FDA QSR under 21 CFR Part 820 is converging with ISO 13485 under the Quality Management System Regulation final rule. For an EU and US dual submission, ISO 13485 with the US-specific additions covers both. The gap analysis reviews design controls, risk management against ISO 14971, software lifecycle against IEC 62304, cybersecurity against the FDA premarket guidance, and post-market surveillance. The output is a remediation plan with owners and dates, not a checklist.
Whether you're launching a new solution or scaling an existing product, Life Value gives you the clarity, speed, and compliance needed to move with confidence.
.webp)
.webp)
.webp)
