Who We Serve: Device Class
Class II Device Manufacturers
Most Class II devices reach the US market through a 510(k), and some through De Novo. That puts design and development records, risk management and change control at the center of every inspection. We help Class II manufacturers find the places where those records stopped agreeing with each other.
Standards and Regulations to Know
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- IEC 62366-1Usability Engineering for Medical Devices
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
Typical Regulatory Exposure
Class II devices are subject to general controls plus special controls, which can include performance testing, specific labeling and device-specific guidance. Most require premarket notification under 21 CFR Part 807, where the firm shows substantial equivalence to a legally marketed predicate. Novel devices of low to moderate risk with no suitable predicate may go through the De Novo pathway instead.
Design and development requirements apply to Class II devices, so the design file has to show inputs, outputs, verification, validation, risk controls and design transfer, and how each one connects to the next. Under the QMSR those requirements come from ISO 13485:2016, which expects risk management to run through the whole product lifecycle.
The harder exposure comes after clearance. Every change to design, materials, suppliers, software or labeling needs a documented decision about whether it affects safety or effectiveness and whether a new 510(k) is needed. Compliance Program 7382.850 treats Change Control and Design and Development as separate inspection areas, and Class II firms with a long product history often have years of undocumented decisions sitting between them.
Where Audits Find Gaps
- 01
Design Inputs That Do Not Trace to Testing
Requirements were revised during development but the verification protocols still test the old values, or test reports exist with no link back to the inputs they verify.
- 02
Missing 510(k) Change Assessments
Changes went through a change order but no documented assessment of whether a new submission was needed, leaving the firm unable to explain why it did not file.
- 03
Risk File Frozen at Clearance
The risk management file reflects the device as submitted. Complaint trends, field feedback and later design changes never made it back into the risk analysis.
- 04
Special Controls Not Mapped
The special controls for the device type are known to regulatory affairs but are not reflected in design inputs, test plans or labeling reviews, so nobody can show they are still met.
- 05
Design Transfer Without Evidence
Manufacturing procedures and inspection criteria exist, but no record shows the design outputs were correctly translated into production specifications.
- 06
Usability Work Done Late
Human factors evidence is a single summative report, with no formative work or use-related risk analysis behind it.
Relevant Standards and Regulations
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- IEC 62366-1Usability Engineering for Medical Devices
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
Questions
Does a 510(k) clearance mean our QMS was reviewed?
No. A 510(k) review looks at the submission, and FDA does not usually inspect the facility as part of it. Your quality system is assessed separately, through inspections that can happen at any point once you are registered.
How far back should a change control review go?
Far enough to cover the design that is on the market today. We usually start with changes since the last clearance for each product family, because that is where a missing 510(k) decision carries the most consequence.
Can you work from our existing design history file?
Yes. Upload it as it is, including exports from the eQMS you already use. The AI-assisted first pass maps inputs, outputs, verification and risk controls to each other, and an advisor reviews every broken link before it becomes a finding.
Our device went through De Novo. Is anything different?
The quality system expectations are the same as for other Class II devices. The difference is that the special controls established with your De Novo grant are specific to your device type, so we check that each one is reflected in your design and production records.
Class II Device Manufacturers
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
