Capability infrastructure · medtech software teams

Software-quality capability, built in-house.

Named medtech Experts do the regulatory work with your team, teach as they go, and hand it back. Built for IEC 62304, ISO 14971, FDA QMSR and IEC 81001-5-1.

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Coverage across the standards every release re-engages
  • IEC 62304
  • ISO 14971
  • ISO 13485
  • FDA QMSR
  • IEC 81001-5-1

Four problems every medtech software team knows.

Named in your own vocabulary.

P-01

Software QA talent is scarce and expensive.

Senior software-quality people in medtech cost more than most teams can sustain. The usual alternative is consultant dependency: high day rates for work your team never learns to do itself.

P-02

Your software engineers are double-hatting as QA.

In SaMD companies with small budgets, the regulatory work lands on the software team. Engineers carry compliance work they were not trained for. The result is patchy IEC 62304 adherence and audit risk that stays hidden until an audit.

P-03

Your quality manager is the mentorship bottleneck.

The only senior software QA person on the team, usually the quality manager, is also the only mentor. Junior upskilling, converting non-software QA hires, and everyday questions all wait on one calendar.

P-04

Compliance is continuous. Mentorship usually is not.

Software-driven medtech products ship updates all the time. Every release re-engages IEC 62304, ISO 14971 and, for connected devices, IEC 81001-5-1. Mentorship and Expert help have to be available at that pace, not booked weeks out.

Consult. Teach. Hand off.

Three modes in one engagement. The Expert leaves and the capability stays.

M1 · Consult

Named Experts deliver the regulatory work alongside your team.

Software development plans, hazard analyses, SOUP qualification and advisory reviews, at production quality, booked at an all-in rate you saw before you clicked.

M2 · Teach

Every deliverable is also a lesson, taught while the work happens.

The Expert walks your manager and learners through the reasoning, the standards behind it and where the audit risk sits, then writes it up as an Advisory Summary filed against the training record.

M3 · Hand off

A controlled handover returns the work, and the know-how to maintain it, to your team.

Ownership moves back to your team with the records your QMS expects: Training Record Packages, Advisory Summaries, named Expert traceability.

Three ordinary weeks.

What the engagement looks like from inside your team.

§ 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 ISO 14971 hazard analysis or the SOUP qualification file. They walk your team through the reasoning section by section as they write it, then hand over the controlled document. Your team ends up with 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 giving up his own afternoons, he assigns the IMSQ role-conversion track. The new hire works through structured modules, paired Expert sessions and a Practical Competency Assessment. The manager reviews the Training Record Package when it is finished, not before.

Structured upskilling that does not queue behind the manager.

§ 03.3

Mid-sprint, an engineer hits a 62304 question.

She opens IMSQ, books a named medtech Expert and has an answer the same day. The Expert writes it up as an Advisory Summary, filed against her training record, so nobody has to ask the same question next sprint.

Expert access at the pace your team ships.

One budget. Every session, every record.

Managers see the month's budget, who booked what, and what is signed off, before anything reaches an invoice.

Budget at the point of booking

Every request shows the all-in rate, the session cost and the budget after. A shortfall is refused with the exact number rather than discovered on an invoice.

Manager-only overage

Learner requests over budget are flagged for one-click Manager approval. Thresholds at 90%, 100% and 110% notify you and IMSQ.

Named Expert on every line

Invoices and advisory outputs carry the Expert's identity, mapped to your supplier-control records.

A monthly capability budget, not a consultant invoice.

Three plans, priced as a budget drawn down at each Expert's published all-in rate.

Published rates, all-in before you book

Every Expert has a published base rate. Your all-in rate is that base plus our management fee (30, 25 or 20% by plan), shown before every booking. There is no blended band and no hidden margin.

Unused budget rolls over

Leftover budget carries forward in full for up to 90 days. Software-quality demand comes in projects, and a short window absorbs that without borrowing from future months.

A bilateral capacity SLA

If IMSQ cannot provide an Expert, the shortfall is made good automatically as a credit carried forward, a refund, or a deduction from the next invoice. You choose which.

Annual is a lower fee, not a coupon

Annual plans carry a lower management fee (25, 20 or 15%) on the same published Expert rates. You can upgrade at any time.

Book a programme review See plans & pricing

Not sure it fits? Start with Section 1.

The first section of the Readiness Diagnostic is free and needs no account or commitment. Send it to the IMSQ team for review, or continue into the full diagnostic when you are ready.

Assess fit (free)

The records your QMS keeps.

Every one of these is written for direct inclusion in your files.

  • AG-01 · Operational, Embedded

    Training Record Package

    Signed attendance, course version, learning objectives, named trainer with retrievable qualifications, assessment evidence, completion status, retention policy.

  • AG-02 · Operational, Embedded

    Practical Competency Assessment

    Scenario-based exercises with competency scoring per learner. Filed against engagement scope.

  • AG-03 · Operational, Embedded

    Advisory Summary

    Structured recommendations, assumptions, limitations, named Expert, Customer Decision Acknowledgement footer.

  • AG-04 · All plans

    Named Expert Traceability

    Every invoice and advisory output carries the named Expert identity. Maps to your supplier-control records.

  • AG-05 · Embedded

    Supplier Qualification Pack

    Controlled, version-numbered, written for direct inclusion in your ISO 13485 §7.4 supplier qualification file.

  • AG-06 · All plans

    Customer Decision Acknowledgement

    A non-guarantee footer on every advisory output, recording that final regulated decisions remain your responsibility.

Who owns what, in every contract, invoice and artefact.

The boundary is written down. That is what lets the model pass procurement and audit review.

IMSQ owns

  • Capability infrastructure
  • Training governance
  • Audit-grade artefacts
  • Supplier-governance materials
  • Operational coordination
  • Continuity of records
  • Facilitated Expert access
  • Bilateral capacity-fulfillment SLA

Independent Experts own

  • Advisory opinions
  • Specialist judgement
  • Implementation guidance
  • Regulated recommendations
  • Their own professional indemnity
  • Subject-matter expertise

You own

  • Final regulatory & quality decisions
  • Internal QMS ownership
  • Process control
  • Engagement on diagnostic & advisory work

Advisory Boundary Clause: IMSQ provides training infrastructure and facilitated access to independent Experts. Final regulated decisions remain the customer's responsibility under their own QMS.

Start with a free fit check.

Access is by invitation after a programme review. Section 1 of the diagnostic is open to anyone.

Assess fit (free)Book a programme review