Why this conversation differs from 2019
If your quality manual, your EU strategy or your monitoring plan was written before 2024, each of these has moved underneath it.
On 2 Feb 2026, 21 CFR 820 became the Quality Management System Regulation, incorporating ISO 13485:2016 by reference. QSIT is retired; FDA now inspects under CP 7382.850. The old §820.180(c) exemption that shielded management reviews, internal audits and supplier audit reports from an investigator was not carried over.
MDR legacy certificates lapse 31 Dec 2027 for Class III and IIb implantables, and 31 Dec 2028 for Class IIb, IIa and Class I sterile/measuring devices. IVDR runs its own staggered clock. Notified body capacity, not your dossier, is usually the schedule risk.
ICH E6(R3) took effect in the EU in Jul 2025 and in Canada in Apr 2026; FDA published it Sep 2025. Quality by design, critical-to-quality factors and documented data governance replace checklist monitoring. Annex 2 follows 15 Jan 2027.
FDA's Predetermined Change Control Plan pathway lets an authorised model be updated without a new submission. In the EU, high-risk obligations for AI embedded in medical devices now land 2 Aug 2028 under the Digital Omnibus agreement — a deferral, not a reprieve.
Who you are dealing with
Privately held and independent every year since. No parent company, no channel partners, nothing in the catalogue we need you to buy.
Share of new business arriving through someone who has already worked with us. It is the only marketing metric we track.
Industry years per consultant. Five years is the floor for joining us, not the average of who is here.
From single-founder start-ups filing a first 510(k) to Fortune 500 manufacturers running multi-region portfolios.
We are not a CRO, a contract manufacturer, a notified body or a software vendor — so there is nothing we are quietly steering you toward. Advice that costs us nothing to give and everything to get wrong is the whole business model. That is why almost all of our work arrives from someone who has already tested it.
Sectors
The arc of a program
Five stages, in order. Find the one you are standing in — it determines what a useful first conversation looks like.
Pathway and classification analysis. Predicate and competitive landscape. IP and reimbursement screen. A go / no-go recommendation with a number attached to it.
Design history file built to ISO 13485. Risk management to ISO 14971. Verification and validation strategy. Human factors. Cybersecurity architecture.
Protocol and critical-to-quality factors under E6(R3). CRO and site selection. IRB / EC submissions, risk-based monitoring, safety reporting, data governance.
510(k), De Novo, PMA, IND, NDA, BLA. MDR and IVDR technical documentation. Agency meetings, deficiency responses, advisory panel preparation.
Tech transfer and process validation. Post-market surveillance and vigilance. Reimbursement execution. Change control, PCCP execution, periodic reporting.
Service lines
Open any line for the full scope. Most engagements draw on two or three at once.
Commercial structure
A named senior operator sitting in your VP of Regulatory, Quality or Clinical seat — one to three days a week, rolling monthly. For companies that need the judgment before they can justify the headcount.
Fixed deliverable, fixed fee, fixed date. A 510(k), a QMS build, a validation package, a remediation plan. Priced from a written scope rather than an hourly estimate that drifts.
Consultants working inside your systems, your document control and your stand-ups for the length of a program. The right answer when the constraint is capacity rather than knowledge.
Audits, due diligence, mock inspections and second opinions — where having no stake in the outcome is the entire value. Findings are delivered to you in writing, unedited.
Differentiation
Six claims you can test, and hold us to.
Twenty-seven years of knowing which arguments have worked with which reviewers, and which have quietly failed. Historical precedent is the cheapest regulatory strategy available.
We track guidance and standards while they are still in consultation, because the requirement that binds you in 2028 is being drafted this year.
You receive documents you can file, defend and hand to an investigator — not slideware summarising a conversation you already had.
If a pathway will not work, you hear it in week one while it is still cheap to hear. Paid confirmation of a decision already made is not a service we offer.
The senior person in the room during the pitch is the senior person on the file. Any change in staffing goes through you first.
Submission windows, board meetings and notified body slots do not move to accommodate a consultant. We plan backwards from your date and flag slippage early.
Next step
Three short, fixed-fee engagements that tell you whether a longer one is worth it.
We read what you have and tell you what the agency is likely to say about it. Written, with the reasoning shown.
Your quality system measured against the regulation in force since 2 Feb 2026, with a remediation sequence ranked by inspection risk.
Which certificates expire when, which products justify the transition cost, and which are better retired from the EU market.
Founded 1999. Independent. Almost every engagement we take begins with a referral from someone who has already tested the advice.