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Regulatory & Quality SpecialistFDA Submissions

Branch · The US file

Regulatory & Quality Specialist:FDA Submissions

The US route: classification, 510(k), De Novo or PMA, and answering FDA questions.

For: Device manufacturers and their regulatory teams preparing US submissions; distributors supporting US partners

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: FDA Submissions: Device Lab, glucometer
Device Lab · glucometer

The arc · 6 weeks · The US file

What you'll be able to do

The job, done properly.

  • Find regulation, class, product code and exemption for a device type
  • Build a substantial equivalence comparison with data for every difference
  • Decide between 510(k), De Novo and PMA and propose special controls
  • Outline a device study with pre-specified endpoints and approvals
  • Make documented change decisions after clearance, including software and cybersecurity

The story

Halcyon Medical's US partner wants filings for the needle-dislodgement monitor, its closed-loop feature and a ventilator accessory. You work the US file with Nadia Al-Khatib, using the public FDA records of real models as your precedents.

Nadia Al-KhatibHead of Regulatory Affairs and Quality, Halcyon Medical · your mentor (a character in the track)
“In the US everything starts from the classification regulation and its product code. Find the code and you find the class, the exemptions, the special controls and every predicate that came before you.”

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: FDA Submissions'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: Pacemaker 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 Rachel Cohen, 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 1Regulation number, product code, predicate
  2. Week 2The 510(k): substantial equivalence on paper
  3. Week 3No predicate: De Novo and the breakthrough designation
  4. Week 4PMA, clinical investigations and the implant
  5. Week 5Changes, software and the questions back (boss week)
  6. Week 6The package: the capstone
  1. Week 1Regulation number, product code, predicate4.2 h

    Two products, no product codes yet, and a US partner who wants a filing date.

    • DoDesign Studio · Signal and Noise: an alarm change on a cleared ventilator20 min
    • See insideDevice Lab 10 · ICU ventilator: the device behind a product code10 min
    • WorkClassification and predicate brief20 min
    • LearnBlueprint ch14 · Regulatory Requirements and Standards (ISO, FDA, IEC)15 min
    • + 10 more steps

    You make: Classification and predicate brief

  2. Week 2The 510(k): substantial equivalence on paper2.9 h

    The monitor's 510(k), and its next firmware change already in the plan.

    • DoDesign Studio · An occlusion sensor that clips on an infusion line20 min
    • See insideDevice Lab 45 · Blood gas analyser: benchtop against cartridge10 min
    • WorkSubstantial equivalence comparison table20 min
    • LearnDevice Design ch7 · FDA Regulations and CE Marking (re-read for the 510(k))10 min
    • + 11 more steps

    You make: Substantial equivalence comparison table

  3. Week 3No predicate: De Novo and the breakthrough designation6.6 h

    A closed-loop feature with no predicate, and a partner who assumes the hardest route.

    • DoDesign Studio · The Algorithm at Night: classify, with the De Novo edge case20 min
    • See insideDevice Lab 27 · Insulin pump: tethered against patch10 min
    • WorkPathway decision: De Novo or PMA20 min
    • LearnDevice Design ch10 · Overview of Clinical Trial Phases10 min
    • + 12 more steps

    You make: Pathway decision: De Novo or PMA

  4. Week 4PMA, clinical investigations and the implant6.4 h

    A leadless pacemaker's public record, and a study that must not enrol before its approvals.

    • DoDesign Studio · A Shock You Wear: the Class III route20 min
    • See insideDevice Lab 24 · Pacemaker (leadless): the fixation tines10 min
    • WorkClinical investigation plan outline20 min
    • LearnDevice Design ch10 · Regulatory Considerations for Clinical Trials15 min
    • + 13 more steps

    You make: Clinical investigation plan outline

  5. Week 5Changes, software and the questions back (boss week)2.2 h

    Four regulatory decisions in one week, each with a clock.

    • DoDesign Studio · A PCA pump interface: software and hardware change20 min
    • See insideDevice Lab 27 · Insulin pump: the pressure sensor zero has drifted5 min
    • WorkChange decision record15 min
    • LearnDevice Design ch7 · Risk Management in Medical Device Design (for change decisions)10 min
    • + 9 more steps

    You make: Change decision record

  6. Week 6The package: the capstone2.3 h

    The US partner receives your package.

    • DoDesign Studio · Asleep on the Machine: the design review20 min
    • WorkCapstone presentation20 min
    • LearnDevice Design ch11 · Key Takeaways from Case Studies10 min
    • ThinkBMEssence · Career Architecture 12: 510(k), PMA and De Novo, the submission architecture15 min
    • + 6 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, FDA Submissions 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 5 of 6 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)

510(k) package outline

For the needle-dislodgement monitor (or one of your devices), a 510(k) package outline: classification, predicate rationale, comparison table, performance data index, standards, software and cybersecurity, biocompatibility, labelling.

Evidence it gives: A reviewable US submission outline.

De Novo request outline or PMA evidence plan

For a device or feature without a predicate, the De Novo request outline (risk level, proposed special controls, evidence) or, if PMA is right, the evidence plan with the study outline.

Evidence it gives: A documented pathway decision.

Change control and decision file

For a cleared device, the change control file for three real or simulated changes (firmware, labelling, a security weakness): risk assessment, submission decision with reasons, verification, records.

Evidence it gives: Change decisions an investigator samples.

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 diagnostic, bed-exit, rhythm devices and respiratory monitor 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.

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