M1Mode
Consult
Named medtech Experts deliver regulatory work alongside your team — software development plans, hazard analyses, SOUP qualification, advisory reviews — at production quality.
§ 00.0 — Capability infrastructure for medtech software
Capability infrastructure for medtech software teams. Built in-house, with on-demand access to named medtech Experts.
For medtech software teams under IEC 62304, ISO 14971, FDA QMSR, and IEC 81001-5-1. Named Experts work alongside your engineers and quality pros — delivering regulatory work, teaching through it, and handing it back. Mentorship, structured upskilling, and execution support, in one engagement.
§ 01.0 — The problem you're living withNamed pains · medtech software teams · 2026
Four pressures that get worse with every release.
Medtech software companies share a remarkably consistent profile of quality-and-compliance strain: scarce senior talent, engineers double-hatting as QA, a single overstretched mentor, and a release cadence that out-runs the team's ability to upskill in real time. IMSQ exists to relieve all four at once.
P-01
SW QA talent is scarce — and expensive.
Senior software-quality professionals in medtech command premiums most teams cannot sustain. Below that line, the alternative is consultant dependency: paying high day-rates for work you never internalize.
P-02
Your software engineers are double-hatting as QA.
At limited-budget SaMD shops, the regulatory work falls on the software team. Engineers carry compliance load they were not trained for; the result is patchy 62304 adherence and quiet audit risk.
P-03
Your quality manager is the mentorship bottleneck.
The only senior SW QA person on the team — usually the quality manager — is also the only mentor. Upskilling juniors, converting non-SW QA hires into SW QA pros, and answering day-to-day questions all queue behind one calendar.
P-04
Compliance is continuous. On-the-fly mentorship is not.
Software-driven medtech products update continuously. Every release re-engages 62304, 14971, and (for connected devices) 81001-5-1. The mentorship and Expert help your team needs has to be available at that cadence — not booked weeks out.
§ 02.0 — How IMSQ changes thatThree modes · one engagement
Your Expert consults, teaches, and hands the work back.
IMSQ's Experts are not just trainers and they are not just consultants. They do the work alongside your team, they teach through it as it happens, and they hand the controlled output — and the reasoning behind it — back to your people. The function ends up internal. The dependency does not.
M2Mode
Teach
Every piece of delivered work doubles as a teaching opportunity. The Expert walks your manager and learners through the reasoning, the standards basis, and the audit-risk surface — as the work happens, not after.
M3Mode
Hand off
Controlled handovers transfer ownership of the work — and the know-how to maintain it — back to your team. The Expert leaves; the capability stays.
§ 03.0 — What that looks like day-to-day3 scenarios · one platform
Three moments your team already lives through.
Each is a real friction point at a medtech software company. Each maps to one of the three modes — consult, teach, hand off — and relieves one of the four pains above without leaving your team less capable on the other side.
§ 03.1
A submission deadline lands, and there is regulatory work to do.
An IMSQ Expert drafts the deliverable to production quality — the IEC 62304 software development plan, the 14971 hazard analysis, the SOUP qualification file. They walk your team through the reasoning section-by-section as it is written, then hand the controlled document over. Your team gets both the deliverable and the know-how to keep it current.
Consult, teach, and hand off — in one engagement.
§ 03.2
A quality manager onboards a non-SW QA hire onto SW QA.
Instead of carving out his own afternoons, he assigns the IMSQ role-conversion track. The new hire moves through structured modules, paired Expert sessions, and a Practical Competency Assessment. The manager reviews the Training Record Package when it is done — not before.
Structured upskilling without manager-as-bottleneck.
§ 03.3
Mid-sprint, an engineer hits a 62304 question.
She opens IMSQ, pulls in a named medtech Expert, gets the answer inside the workday. The exchange is captured as an Advisory Summary and filed against her training record — so the same question does not get re-asked next sprint by someone else.
On-demand Expert access at the cadence your team actually ships at.
§ 04.0 — Coverage levels & pricingMonthly $ budget · annual = lower fee
Disclosed prices.
Disclosed margin.
Three plans, each a monthly capability budget. Your all-in rate is each Expert's published base plus our management fee (30% / 25% / 20%), shown before you book — no blended band, no hidden margin. Annual is a lower management fee, not a coupon.
F
Foundational Coverage
$1,300/ mo
30% mgmt fee · $15,000/yr
A monthly capability budget for general 62304 Expert work — structured trainings, completion records, and basic capability tracking, drawn down at each Expert’s published all-in rate.
- ✓Monthly capability budget within a defined scope
- ✓General Expert advisory access (62304 / 14971 / QMSR)
- ✓Trainings consume budget (8-course catalog)
- ✓Basic capability tracking
- ✓Readiness Diagnostic on first engagement
Most teams
O
Operational Coverage
$5,000/ mo
25% mgmt fee · $57,600/yr
A larger monthly budget plus Training Record Packages, Practical Competency Assessments, and Advisory Summaries with named Expert attribution.
- ✓Everything in Foundational
- ✓1 included Program-Leader hour / month
- ✓Training Record Packages
- ✓Practical Competency Assessments
- ✓Advisory Summaries · named Expert attribution
E
Embedded Coverage
$9,600/ mo
20% mgmt fee · $110,400/yr
The largest monthly budget plus the Supplier Qualification Pack, browse access to the Expert Qualification Registry, and DHF-suitable advisory documentation.
- ✓Everything in Operational
- ✓4 included Program-Leader hours / month
- ✓Supplier Qualification Pack (versioned)
- ✓Expert Qualification Registry · browse
- ✓DHF-suitable controlled advisory docs
Each Expert has a published base rate from $100/hr (Cybersecurity / AI-ML from $130, Program-Leadership from $150); your all-in rate is base + the plan management fee, shown before every booking. Pricing is provisional and subject to change. See the full ledger for the Expert-rate card and worked example.
§ 05.0 — The records your QMS keeps6 controlled outputs · produced as part of normal operations
Operational governance, not an administrative extra.
The work above leaves a trail. Training Record Packages, Practical Competency Assessments, Advisory Summaries with named Expert attribution, the Supplier Qualification Pack — produced as the work happens, ready for your QMS and for any auditor who asks. Outcomes still depend on your QMS and how you use them.
CodeArtefactDescriptionIncluded in
AG-01Training Record PackageSigned attendance, course version, learning objectives, named trainer with retrievable qualifications, assessment evidence, completion status, retention policy.OE
AG-02Practical Competency AssessmentScenario-based exercises with competency scoring per learner. Filed against engagement scope.OE
AG-03Advisory SummaryStructured recommendations, assumptions, limitations, named Expert, Customer Decision Acknowledgement footer.OE
AG-04Named Expert TraceabilityEvery invoice and advisory output carries the named Expert identity. Maps to your supplier-control records.FOE
AG-05Supplier Qualification PackControlled, version-numbered, written for direct inclusion in your ISO 13485 §7.4 supplier qualification file.E
AG-06Customer Decision AcknowledgementExplicit non-guarantee footer on every advisory output. Records that final regulated decisions remain customer responsibility.FOE
F = Foundational · O = Operational · E = Embedded. Outcomes governed by your QMS — see § Boundaries.
§ 06.0 — Boundaries & responsibilitiesReflected in every contract, invoice, and artefact
Three parties. Three sets of ownership.
The boundary between IMSQ-supplied infrastructure, the independent Expert's advisory work, and your team's ownership of regulated decisions is named in every contract. Every advisory output carries a Customer Decision Acknowledgement footer recording this.
COL · 01
IMSQ owns
- ›Capability infrastructure
- ›Training governance
- ›Audit-grade artefacts
- ›Supplier-governance materials
- ›Operational coordination
- ›Continuity of records
- ›Facilitated Expert access
- ›Bilateral capacity-fulfillment SLA
COL · 02
Independent Experts own
- ›Advisory opinions
- ›Specialist judgement
- ›Implementation guidance
- ›Regulated recommendations
- ›Their own professional indemnity
- ›Subject-matter expertise
COL · 03
You own
- ›Final regulatory & quality decisions
- ›Internal QMS ownership
- ›Process control
- ›Engagement on diagnostic & advisory work
ADVISORY BOUNDARY CLAUSE · contract excerpt ›"IMSQ provides training infrastructure and facilitated access to independent Experts. Final regulated decisions remain the customer's responsibility under their own QMS."
Schedule a 30-minute
capability review.
We'll walk through your team's current SW QA capability — where the gaps sit, how much of your managers' time is going to mentorship, and which coverage level matches the lift. You leave with the free Readiness Diagnostic output and a draft Capability Gap Assessment scope.