Be Ready When FDA Knocks
QMSR Investigation Readiness for Medical Device Manufacturers
An FDA investigation can happen without warning. Under the new Quality Management System Regulation (QMSR), being “mostly compliant” is no longer enough.
If FDA walked through your door tomorrow, would your team know:
- What QMSR actually requires?
- What FDA investigators can now ask to see?
- How to explain your system—confidently and consistently?
If the answer is maybe or it depends on who’s in the room, this course is for you.
Why This Matters Right Now
QMSR is in force.
The old Quality System Regulation (QSR) and QSIT investigation model are gone.
That means:
- ISO 13485:2016 is now formally incorporated into FDA’s Part 820
- FDA’s investigation authority is unchanged—and broader in practice
- Internal audits, management reviews, and supplier audits are now fair game
- Past “good” investigations and ISO certificates do not protect you
FDA has made it clear:
Senior management is accountable, and quality culture will be evaluated—not just procedures.
Companies that wait are learning under pressure.
Companies that act now are setting themselves up for the next 8–10 years.
What This Course Does (Simply)
This is not theory.
This is investigation-ready training designed to help your team perform when FDA is in the building.
By the end of the course, your team will be able to:
- Clearly explain what QMSR is and why FDA changed the rules
- Understand what changed vs. what stayed the same from legacy QSR
- Translate FDA’s QMSR preamble and industry responses into real investigation expectations
- Identify gaps in your current quality system and prioritize what actually matters
- Prepare for FDA’s new, risk-based, MDSAP-influenced investigation posture
- Understand why ISO 13485 certification alone is not enough for U.S. compliance
- Strengthen risk management, training, and management accountability
- Create and maintain audit and management review records that stand up to FDA scrutiny
Most importantly:
Your team will speak the same QMSR language—calmly, consistently, and credibly.
Who This Is For
If FDA might talk to them, they should take this course:
- Quality & Regulatory Affairs
- Operations & Manufacturing Leadership
- R&D / Design & Development
- Supplier Quality & Supply Chain
- Senior Management with QMS responsibility
FDA has been explicit: QMSR applies to every finished medical device manufacturer selling into the U.S.A.
Investment & Access
$499 USD per learner (powered by ZenSpace Publishing Inc.) Buy now
Includes:
- 6 months of full access to all modules
- Practical tools and frameworks
- Ongoing updates as FDA refines its QMSR-based investigation approach
- Free access extensions on request—so no one is locked out before an investigation
Train once.
Refresh often.
Onboard new hires without scrambling.
Why You Should Enroll Now
Unless it’s a for-cause investigation, the FDA preannounces their visits, but with only 7 days or less notice.
Every untrained employee increases the risk of:
- Investigation findings
- Warning letters
- Costly remediation
- Delays to product, growth, or funding
This course gives your organization a shared, investigation-ready foundation—before FDA tests it for you.
Enroll Today
An FDA investigator can knock any day.
Enroll your quality, regulatory, operations, and leadership teams in the QMSR Investigation Readiness Course now—and make sure the first investigation question doesn’t become your first mistake.
Reserve seats for all affected employees today. $497 per learner ( powered by ZenSpace Publishiing Inc.)