ipp. easy13485The MedTech Field Guide · No. 0400
Topic of the month · The CEO & Management ReviewNo. 04 · 2026
ipp. academy

Congratulations, you're management now.

You wanted to build a product. Surprise — you're ‘top management’ with quality objectives and a meeting that becomes a controlled record.

Turn the page
Chapter 01 · Cold open

You can delegate the slides.
You cannot delegate the responsibility.

Somewhere between the seed round and the first audit, you became ‘top management’ — a role with homework: quality objectives, resources, and decisions on the record. The Management Review isn't corporate theatre. It's the one meeting where ‘we'll get to it’ is forced to become a controlled record with a date and an owner.

You don't need to run the QMS. You need to decide on it — out loud, once a rhythm, on paper. I'll bring the inputs.
Chapter 02 · Role reality

The CEO owns the ‘so what?’

The CEO owns

  • quality objectives — with numbers, not adjectives
  • resources: people, time, budget
  • the decisions, and releasing the review
  • that follow-ups from last time actually closed

The CEO does not own alone

  • preparing every input — the QMR assembles them
  • attending as a passive CC recipient
  • doing the fixes — owners own the actions
  • the QMS as a solo hobby somewhere in the org
Chapter 03 · The wrong way

Management theatre, and how to cancel the show.

  • Signing what you didn't read (the signature is the easy part; the reading is the job)
  • The annual review, performed the night before, from memory
  • Quality objectives that are posters, not numbers
  • Treating the QMS as ‘the QMR's thing’
  • ‘Management commitment’ that exists only as a slide
Absolutely not a product

DelegationAway™

Spray it on any responsibility and watch it become someone else's problem!* Works on everything except the things that matter.

Responsibility is the one thing the MDR won't let you delegate. Everything else, sure — delegate away.
Chapter 04 · The easy13485 way

Inputs go in. Decisions come out.

01 · Prepare

Assemble & perform

The QMR prepares inputs (1.3.1.3); you and the QMR evaluate the data with the controlled template (1.3.1.5 · T02-001).

Perform Mgmt Review
02 · Decide

Decide, release, resource

You review and release (1.3.1.6), set QM objectives (1.2.2.2) and plan the resources to meet them (6.1.1.1).

Define QM Objectives
03 · Follow-up

Close the loop

Actions move into tracked follow-up (1.3.1.8 · T02-010) and, where needed, CAPA — so decisions don't evaporate.

Follow-up Measures
A good review is boring in the best way: the data is ready, the decisions are clear, and last time's actions are already closed.
Chapter 05 · Recurring design

The decisions land in Operate & Scale.

Objectives set the target early; the Management Review is where leadership keeps the whole system honest.

Stage 01
Claim Check
Know what you are.
▸ objectives get a target
  • Intended use & class
  • Route & scope
  • Light · Essential · Certified
Stage 02
Explore & Plan
Plan the resources.
▸ resources planned
  • Evidence strategy
  • Roles & capacity
  • Realistic timeline
Stage 03
Build & Document
Decisions on record.
▸ controlled records
  • Design & review records
  • Objective evidence
  • Traceable choices
Stage 04
Automate
The QMS prepares the meeting.
▸ inputs assembled
  • Data pulled together
  • Draft review record
  • Judgement stays human
Stage 05
Operate & Scale
Where leadership decides.
▸ review & follow-up
  • Management Review
  • Objectives & resources
  • Follow-up that closes

The review isn't where you find out how things are going. It's where you decide what happens next — on the record.

Walk the full Journey
Chapter 06 · Assets shelf

The CEO shelf — proof, tools and the source map.

All resources
Chapter 07 · Do this next

Three moves before your next review.

1

Write three real quality objectives

With numbers and owners, not adjectives. ‘Better quality’ is not a target; ‘<2% complaint rate by Q3’ is.

2

Book the review as a recurring meeting

A surprise review isn't a review. Put it in the calendar and protect the slot.

3

Check last review's follow-ups actually closed

An open action is just a promise with a date. Close them before you open new ones.

The MedTech Field Guide
No. 04 · CEO Edition · 2026
The full story

Sign last. Ask first.

The full Management Review process, the controlled templates and role training live in the Makerspace and on ipp-nbg.de. Bring last quarter's objectives — we'll help you make the next review a decision, not a performance.

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Field Guide No. 04 · 2026
A recurring series. Next: QMR.