Scattered regulatory sources
Updates may appear across regulations, guidance documents, recognized standards, safety communications, submission programs and compliance materials.
RegWatch for Medical Device Companies
Stay ahead of medical device regulatory change—without adding more manual work.
Monitor the FDA, quality-system, premarket, clinical, labeling, reporting, postmarket and cybersecurity sources your organization selects. When something changes, RegWatch helps regulatory, quality, clinical, engineering and security teams understand what changed, what may be affected and what to review next.
No credit card required for the free monitoring account.
Regulatory change command center
FDA QMSR
ISO 13485
21 CFR Part 803
21 CFR Part 806
Registration & Listing
UDI & GUDID
Premarket Submissions
Device Cybersecurity
Why RegWatch
Medical device compliance spans the full product lifecycle.
Requirements and guidance may come from FDA regulations, CDRH programs, recognized consensus standards, premarket pathways, inspection materials and state authorities. RegWatch brings the sources you select into a consistent monitoring and review process.
Product and pathway differences
Watchlists may need to reflect device classification, product code, submission type, establishment role, technology and market status.
Quality documents can lag behind change
Teams need a repeatable way to connect new requirements with procedures, design controls, risk files, labeling and postmarket processes.
Alerts need lifecycle context
Reviewers need the source, dates, affected topics and a clear path to assign regulatory, quality, engineering and security follow-through.
Monitoring Coverage
Build a watchlist around your devices, markets and quality system.
Select the regulations, guidance, standards and program materials that matter to your products and operations. Expand coverage as portfolios, technologies, establishments and obligations change.
Quality management and inspections
Selected FDA QMSR and 21 CFR Part 820 materials, ISO 13485-related sources, inspection programs, quality-system guidance and recognized standards.
Premarket pathways and submissions
Selected 510(k), De Novo, PMA, IDE, Q-Submission, eSTAR and product-specific FDA guidance relevant to your regulatory strategy.
Registration, listing, UDI and labeling
Establishment registration and device listing, UDI and GUDID materials, labeling requirements and selected product-identification sources.
Safety reporting and postmarket action
Medical Device Reporting under 21 CFR Part 803, corrections and removals under Part 806, recalls, safety communications and surveillance materials.
Clinical and product-development requirements
Selected IDE, human-subject protection, institutional review board, design and development, risk-management and clinical evidence sources.
Software and device cybersecurity
Selected FDA digital-health and cybersecurity guidance, FD&C Act section 524B materials, software documentation and postmarket vulnerability sources.
Monitor availability and applicability vary by source, device, establishment role and organization. Your team chooses the watchlist it wants RegWatch to follow.
How RegWatch Works
Move from “something changed” to a focused review process.
Select your monitors, receive organized change intelligence and optionally connect policies for gap assessment.
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1
Select your monitors
Choose the regulations, FDA programs, guidance, standards, product areas and postmarket sources your organization wants to follow.
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2
Review focused change summaries
See what changed, important dates, affected requirements, source links and suggested review areas.
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3
Connect documents when useful
Upload and assign quality procedures, regulatory plans, risk files, labeling controls, cybersecurity documents or reporting procedures.
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4
Assess gaps and document action
Review potential document gaps, clarification or remediation needs, ownership, review activity and supporting evidence.
Illustrative workflow
New Update
A change is detected. Your team sees the context.
1
Monitor
Selected source
Actively monitoring
RegWatch follows the regulation, guidance, standard, safety communication or program source your team selects.
2
Detect
Change identified
Change Alert Detected
Medical Device Update
New
+
Requirement updated
Source captured and compared with the previous version.
The update is captured, summarized and organized so reviewers can focus on what changed.
3
Review
Context delivered
RegWatch Review
Ready for your team
Ready
SummaryWhat changed
Key datesWhen it matters
PoliciesWhat to review
Next stepsWho owns action
Assigned to regulatory, quality and engineering reviewers
Your team receives a focused review package instead of another unstructured alert.
Built for Medical Device Companies
One monitoring approach for diverse devices and operating models.
RegWatch can support organizations with different device classes, submission pathways, manufacturing roles and technology profiles—without forcing every product team into the same watchlist.
Create your free monitoring account
Medical device manufacturers
In vitro diagnostic and laboratory device companies
Digital health and software medical device teams
Contract manufacturers and specification developers
Device importers and U.S. agents
Multi-product and multi-establishment device organizations
What Your Team Gains
A more manageable way to stay aware, assess impact and document follow-through.
Less manual source tracking
Reduce repeated searches across individual FDA, standards, safety and program websites.
More focused reviews
Give owners the source, dates, affected lifecycle topics and review context in one place.
Stronger document traceability
Connect selected requirements with the quality procedures, controls and records your teams rely on.
A clearer review record
Keep updates, assessments, assignments, decisions and supporting evidence organized.
Frequently Asked Questions
Medical device monitoring, without another spreadsheet.
Start with regulatory monitoring, then add policy assessment workflows when your team is ready.
Talk to AllgressWhich medical device requirements can RegWatch monitor?
Companies can build watchlists from available selected sources such as FDA regulations and guidance, the Quality Management System Regulation, recognized consensus standards, premarket submission materials, Medical Device Reporting, corrections and removals, establishment registration and listing, UDI, labeling, clinical investigation, and cybersecurity sources. Available coverage depends on the selected monitors and sources.
Does RegWatch cover the FDA Quality Management System Regulation?
RegWatch can monitor selected QMSR and related FDA sources when those monitors are available and chosen by your organization. The revised 21 CFR Part 820 became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference, with additional FDA requirements. Your organization remains responsible for determining applicability and implementation.
Can we use RegWatch without uploading quality documents?
Yes. You can use RegWatch for regulatory monitoring and change alerts without uploading procedures or quality documents. Uploads are optional and enable policy and document assessment workflows.
How does document assessment work for medical device companies?
You assign uploaded quality procedures, design and development documents, complaint-handling procedures, reporting procedures, labeling controls, cybersecurity plans or other documents to relevant monitors. When selected requirements change, RegWatch can identify areas that may require review, clarification or remediation.
Does RegWatch determine device classification or replace regulatory counsel?
No. RegWatch provides regulatory intelligence, workflow support and document assessment assistance. Your organization remains responsible for device classification, regulatory strategy, applicability decisions and obtaining legal, quality, clinical or regulatory advice where needed.
Start with the sources that matter to you
Make medical device regulatory monitoring easier to manage.
Get a free RegWatch account and begin building your organization’s monitoring watchlist.