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Regulatory & Quality SpecialistPost-market Surveillance & Recalls

Branch · The loop that learns

Regulatory & Quality Specialist:Post-market Surveillance & Recalls

After launch: complaints, trend reports, field safety notices and recalls.

For: Manufacturers' quality and vigilance teams, distributors, and hospital medical device safety and quality teams

Before you start: The Regulatory & Quality Specialist core track, or its baseline check at Medium or above

Start free: week 1 of a trackBook a demo for your team
Your mentor, a character in the trackNadia Al-KhatibHead of Regulatory Affairs and Quality, Halcyon Medical
Length
6 weeks
Time
About 4 hours a week
Levels
Easy, Medium, Hard
Certificate
Certificate of Completion
On your own
$199, 12 months
Regulatory & Quality Specialist: Post-market Surveillance & Recalls: Patient Safety simulation
Patient Safety simulation

The arc · 6 weeks · The loop that learns

What you'll be able to do

The job, done properly.

  • Recognise and triage complaints with reportability decisions
  • Investigate with evidence preserved and causes you can change
  • Trend with thresholds and close CAPA on effectiveness
  • Run field actions to closure on evidence for every unit

The story

You run post-market work for Halcyon Medical's own products and the products it distributes, side by side with the medical device safety officer of Medical City Hospital. Nadia Al-Khatib mentors you.

Nadia Al-KhatibHead of Regulatory Affairs and Quality, Halcyon Medical · your mentor (a character in the track)
“A complaint is any report that a device did not meet its claims, harm or not. 'User error' is a conclusion, not a category; most of them are design or labelling signals.”

Inside the track

What you actually use, every week.

The real screens: My track, a step with your mentor, a simulation, your skills map and the certificate.

My track
My trackThe arc of 6 weeks, this week's case, your mentor and your next step, in Regulatory & Quality Specialist: Post-market Surveillance & Recalls's own colours.
A step with your mentor in the Device Lab
A step with your mentor in the Device LabThe step names what to look at on the real device, with hints that never give the answer away.Shown: Cardiac Monitor with Nadia Al-Khatib, this track's mentor
A simulation
A simulationReal hospital work in Medical City, scored and debriefed, at your level.
Your skills map
Your skills mapThis track's own competencies, from your baseline to mastery. They move only on evidence.Shown: a sample learner's progress
The certificate
The certificateA Certificate of Completion in the track's colours, with the work behind it.Shown: a sample for Zainab Ali, a fictional learner

The arc

6 weeks, one running case.

Each week is one working shift: learn, see inside, do, work, think, check, reflect. Open a week to see its real steps.

Gate by gate

  1. Week 1Every report is a complaint until proven otherwise
  2. Week 2Investigate without destroying the evidence
  3. Week 3Trends, signals and CAPA that works
  4. Week 4The field safety corrective action
  5. Week 5Three notices, one unread, one delayed harm (boss week)
  6. Week 6A post-market system that learns: the capstone
  1. Week 1Every report is a complaint until proven otherwise6.5 h

    140 items in an inbox, half closed as 'user error'.

    • DoPatient Safety · The Ten-Fold Dose20 min
    • See insideDevice Lab 56 · Infusion pump: display and controls10 min
    • WorkComplaint re-triage with reportability screen20 min
    • LearnClinical Engineering ch6 · Safety Reporting and Documentation15 min
    • + 11 more steps

    You make: Complaint re-triage with reportability screen

  2. Week 2Investigate without destroying the evidence3.6 h

    A quarantined syringe pump, a waiting representative, and a family asking what happened.

    • DoPatient Safety · The Bolus on Release20 min
    • See insideDevice Lab 56 · Infusion pump: downstream pressure sensing10 min
    • WorkJoint investigation protocol20 min
    • LearnClinical Engineering ch10 · Risk Management during Adverse Events15 min
    • + 12 more steps

    You make: Joint investigation protocol

  3. Week 3Trends, signals and CAPA that works3.5 h

    Three 'no fault found' returns, a doubling of alarm complaints, and a CAPA board that closes on dates.

    • DoTech Detective · Every Tuesday20 min
    • See insideDevice Lab 38 · Cardiac monitor: electrodes on for three days10 min
    • WorkTrend review and CAPA20 min
    • LearnClinical Engineering ch8 · Benchmarking Indicators for Clinical Engineering15 min
    • + 12 more steps

    You make: Trend review and CAPA

  4. Week 4The field safety corrective action6.2 h

    Battery packs in four hospitals, in devices, in drawers and in places nobody wrote down.

    • DoOperations Manager · Defibrillator battery notice: find every pack20 min
    • See insideDevice Lab 19 · Defibrillator: charging becomes slow10 min
    • WorkField safety corrective action plan with notice20 min
    • LearnClinical Engineering ch10 · Steps in the Medical Device Recall Process10 min
    • + 12 more steps

    You make: Field safety corrective action plan with notice

  5. Week 5Three notices, one unread, one delayed harm (boss week)2.2 h

    Three notices, one forgotten, one injury that took six weeks to show.

    • DoMaster Challenge · Three notices before breakfast20 min
    • See insideDevice Lab 56 · Infusion pump: free-flow protection5 min
    • WorkUnread notice investigation15 min
    • LearnClinical Engineering ch13 · Case Studies on Patient Safety Failures and Successes10 min
    • + 7 more steps

    You make: Unread notice investigation

  6. Week 6A post-market system that learns: the capstone1.7 h

    The auditor reads your post-market work.

    • WorkCapstone presentation20 min
    • LearnDevice Design ch10 · Post-Market Surveillance10 min
    • CheckWarm-up: retrieval from earlier weeks (spaced)8 min
    • Your organisationYour organisation's post-market procedures: final cross-check10 min
    • + 4 more steps

    You make: Capstone presentation and sign-off

Proof

Only evidence counts.

A step is done when there is evidence: a simulation score, a saved work document, a passed check or a signed observation. Opening a page never ticks anything.

  • Before and afterThe same baseline check on day one and in the final week, scored per competency.
  • Mastery, not attendanceEach competency has a mastery threshold. Below it, the track routes you to the named remediation items and a re-check; a week cannot be ticked complete by opening items alone.
  • The audit packYour weekly work documents and capstones, ready for a supervisor, an employer or an inspector.

The certificate

BMEssentia Certificate of Completion: Regulatory & Quality Specialist, Post-Market branch

It names the track and the level you completed. Your portfolio holds the work behind it.

  • All 6 weeks' required items done at the learner's level
  • At least 3 of 4 competencies mastered
  • Final check at or above the level's pass mark
  • Capstone at 3 or above on every criterion, signed off by the manager or professor (institutions) or AI-assisted rubric review (individuals)

Post-market system design

Design (or redesign) a post-market system for one product line: intake, triage and reportability screen, investigation route, indicators with thresholds, CAPA rules, field action procedure, and the feedback to risk file and labelling.

Evidence it gives: A PMS system an auditor can follow.

Full investigation file

One real or simulated incident investigated end to end: custody, protocol, tests, root cause, reportability, communication, actions on every side.

Evidence it gives: An investigation file of the kind regulators request.

Field action from decision to closure

One real or simulated field action: decision, notice, identification of every unit, interim measures, fix, verification, acknowledgements, regulator communication and closure evidence.

Evidence it gives: A field action closed on evidence.

Three levels

Easy, Medium or Hard.

A baseline check on day one places you, or you choose. The competencies are the same at every level; the support and the pressure change.

Easy

Baseline under 50%, or chosen · simulations at Foundation

Worked examples first; Foundation simulations with the coach; the extra cases hidden.

Medium

Baseline 50% to 74%, or chosen · simulations at Practitioner

Practitioner difficulty; the fleet battery, device death, threshold and overnight notice cases shown.

Hard

Baseline 75% and above, or chosen · simulations at Expert

Expert difficulty, every case, timed boss week.

Ways to get this track

On your own, with a plan, or with your organisation.

Deep Dive

This Deep Dive

$199for 12 months

  • The track's lessons, labs and Medical City scenarios
  • The certificate when you finish
  • The track mentor: 100 questions for the track, more with credit top-ups
  • Or the Regulatory & Quality Specialist Full family: $849

General Essentia, the Studios and Design are not included. Subscribe within 30 days and what you paid counts toward your plan.

Start free: week 1 of a track

Premium · Pro

Included in Premium and Pro

$299a year with Premium

  • Premium: 1 active track family at a time, this one or any other
  • Pro: 3 active track families at a time, with heavy AI use
  • Or Premium at $39 a month; one-time tracks cost 25% less with Premium, 40% less with Pro
Get Premium

Organisation licence

Every track for every seat

  • Every track and product, and the dashboard
  • Enrol people or cohorts and follow their progress
  • Seats for a year, an academic year or a semester
Book a demoOrganisation prices

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FAQ

Answers before you start.

Anything else, write to the team and we answer directly.

Contact us

  • Yes. An organisation's licence includes every track, core and branch, with the Platform, Medical City, Essentia, the App and the dashboard. Your organisation enrols you on the track, and it appears under My track; there is nothing extra to buy.

Start free: week 1 of a trackRequest a demo