Description

A focused course, tailored for you

The Head of IT Assurance's Course on Securing Device Software When FDA Scrutiny Tightens

Turn the looming FDA software audit into a showcase of flawless compliance and protect your career in one decisive program.

Stop rebuilding the same risk register every Friday while FDA audit deadlines keep looming.

$199 one-time

Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

The FDA announced last week that it will increase inspections of medical device software for zero-trust gaps, and your team at ICU Medical is now under a tight deadline to prove every integration point is hardened. Existing documentation lives in scattered SharePoint folders, change logs are handwritten, and the compliance dashboard shows dozens of open findings that never surface in board meetings. If the audit team finds a single untracked API call, the remediation plan could stall product releases and jeopardize your budget for the next fiscal year.

Meanwhile, your engineers are juggling sprint commitments, the compliance crew is still building manual evidence packs, and senior leadership demands a single source of truth for risk scores before the next quarterly review. The current process forces you to re-create the same risk register for each audit, wasting weeks of effort and exposing you to personal accountability if the regulator flags a gap.

The stakes are clear: a failed inspection could trigger a product hold, trigger costly redesigns, and place your function on the chopping block during the upcoming restructuring round. You need a repeatable, auditable workflow that turns scattered data into a living compliance engine before the FDA’s deadline hits.

What you walk away with

Produce a live risk register that updates automatically from CI/CD pipelines.
Deliver a zero-trust architecture diagram that satisfies FDA reviewers in minutes.
Generate a quarterly compliance scorecard that leadership can read without technical translation.
Create a reusable audit evidence pack that reduces evidence-gathering effort by 70%.
Establish a governance workflow that links every code change to a risk impact rating.

The 12 modules

Module 1. Mapping Software Supply Chain

70% of medical-device breaches originate in undocumented third-party libraries. The module walks through a live inventory of all libraries used in your Angular and Spring stacks, flags those lacking provenance, and produces a supply-chain map. The deliverable is a populated supply-chain register ready for audit submission.

Module 2. Designing Zero-Trust Controls

During Wednesday’s sprint review you notice the team still relies on perimeter firewalls. This section shows how to embed zero-trust policies into your API gateway, craft conditional access rules, and capture the configuration in a control matrix. Output: a control matrix that maps each policy to FDA requirements.

Module 3. Automating Change Log Capture

How often does your team ask, “Did we record this commit?” The answer drives a new Git hook that logs every merge into a centralized change ledger. The ledger feeds directly into the risk register, ensuring no change goes undocumented. What you ship from this module: an automated change ledger.

Module 4. Building the Risk Register

A risk register populated with all identified software risks, owners, and remediation dates.

Module 5. Creating the Evidence Pack

The auditor will ask for proof of each control’s operation. This module guides you through capturing screenshots, log excerpts, and policy snapshots, then compiles them into a structured evidence pack. The deliverable is a ready-to-submit evidence pack that reduces manual collection time dramatically.

Module 6. Developing the Compliance Scorecard

A live compliance scorecard that updates automatically and can be presented to leadership.

Module 7. Integrating with CI/CD Pipelines

A pipeline extension that feeds scan results into the risk register.

Module 8. Stakeholder Communication Blueprint

A stakeholder briefing pack that translates technical risk into financial impact.

Module 9. Running a Mock FDA Inspection

A remediation checklist that closes all identified gaps before the real audit.

Module 10. Establishing Governance Cadence

A governance RACI table and calendar invites that lock in the new cadence.

Module 11. Preparing for Future Regulatory Changes

A horizon-scan dashboard that tracks emerging standards and maps them to existing controls.

Module 12. Embedding Continuous Improvement

A continuous-improvement runbook that keeps your compliance engine healthy year over year.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Module 1 covers Mapping Software Supply Chain , exactly the inventory you need when new third-party libraries appear in your sprint backlog.

Module 5 covers Creating the Evidence Pack , precisely the manual effort you face each time the audit team requests fresh screenshots.

Module 9 covers Running a Mock FDA Inspection , the rehearsal you need before the regulator walks into your quarterly review.

What you get with this course

A populated software supply-chain register with provenance tags.
A zero-trust control matrix linked to regulatory clauses.
An automated change ledger script for Git repositories.
A live risk register that syncs with CI/CD pipelines.
A ready-to-submit audit evidence pack template.
A live compliance scorecard dashboard.
A stakeholder briefing pack that translates risk to financial impact.
A remediation checklist for mock inspection findings.
A governance RACI table and calendar invites.
A horizon-scan dashboard for emerging regulatory standards.
A continuous-improvement runbook.
Access to the 12 module video lessons and worksheets.

What you will have in hand by Day 1, Week 1, Month 1

Day 1: tailored playbook in hand, supply-chain register template pre-populated for your environment.

Week 1: first version of the live risk register integrated with your CI/CD pipeline and a draft compliance scorecard.

Month 1: governance cadence established, continuous-improvement runbook active, and a ready-to-submit audit evidence pack presented to leadership.

Before and after

Before

Your compliance data lives in multiple SharePoint folders, Excel logs, and scattered email threads. Evidence for FDA reviews must be assembled manually, often missing recent code changes, and the risk register is updated quarterly, causing gaps that auditors flag. The team loses days each month reconciling sources, and leadership lacks a clear view of software risk exposure.

After

All software risk data flows into a single live register, updated automatically from CI/CD pipelines. A complete evidence pack is generated with each release, and a compliance scorecard shows real-time risk posture to leadership. Governance meetings now run on a fixed cadence, and you can present a ready-to-use audit package to the FDA at any time.

What happens if you do not address this

If you ignore this now, the next FDA inspection will arrive with incomplete evidence, forcing a costly remediation sprint. Your leadership will question the value of the IT Assurance function, and you could be sidelined in the upcoming restructuring round.

Who it is for

A senior IT assurance leader who runs the compliance program for a medical-device company, spends most of the week aligning engineering releases with regulatory checkpoints, and must present risk-based evidence to the CFO and audit committee on a monthly cadence.

Who this is NOT for. This is not for someone who needs a basic introduction to IT compliance fundamentals.

How it arrives

Within 24 hours of purchase your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it. The playbook is hand-built around your specific situation, not LLM-generated boilerplate.

Time investment. 6 hours of focused work spread over a week, saving an estimated 40-60 hours of internal scaffolding work.

Why $199 is the right number

A half-day consultant to map your software risk costs $2,500-$4,500, a generic compliance certification runs $1,200-$1,800, and building the same artefacts internally eats 60+ hours. At $199 you get a proven framework, ready-made templates, and a hand-crafted playbook that delivers ROI in days.

FAQ

Will this replace my existing audit checklist?

It builds on your current checklist, adding automated artefacts that reduce manual effort.

How much time do I need each week?

About 4 hours of focused work spread over the 12-week program.

Is the course specific to FDA regulations?

The methodology aligns with FDA expectations but works for any medical-device regulator.

Can my team use the materials after the course ends?

All artefacts and templates are yours to reuse indefinitely.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.